A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients With Residual FVIII Levels ≤ 1 IU/dL Receiving Prophylactic FVIII Infusions
Phase: PHASE3
Conditions: Hemophilia A
Sponsor: BioMarin Pharmaceutical

 
 
 
 
    
 
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Note to File (NTF) 
Project No.: 
BMN 270; Study 270-301 
Project Name (If Applicable): 
To align the 270-301 Protocol (version 7.0, 15 July 2021; US-specific) and the 2-
year analysis SAP (version 2.0, 13 December 2021) with the 2-year 270-301 CSR 
Location: 
NA 
Subject:  
NTF to bridge the 270-301 protocol (version 7.0, 15 July 2021; US-specific) and 
the 2-year analysis SAP (version 2.0, 13 December 2021) with the 2-year 270-301 
CSR for primary and secondary endpoints and other changes made to the 2-year 
analyses.  
Date 
02 March 2023 
Overserved Discrepancy – Primary and secondary endpoints and statistical analysis methods used in the 2-year 
270-301 CSR were modified from those specified in the effective versions of the 270-301 protocol (version 7.0, 15
July 2021; US-specific) and the 2-year analysis SAP (version 2.0, 13 December 2021).
Background – The 2-year analysis of Study 270-301 was performed in January 2022 based on pre-specified analysis 
methods in the 2-year analysis SAP. Type B Pre-BLA feedback was received from FDA on 16 May 2022. FDA 
requested changes to the analysis methods, including primary and secondary endpoints. The results reported in 2-
year 270-301 CSR reflect the modified analysis methods per FDA feedback and this CSR was submitted to the FDA 
on 29 September 2022, in the BLA re-submission. Changes from the planned analysis methods were documented 
in Section 9.8.2 of the CSR (Changes to Planned Analyses). 
Solution – This NTF serves as a bridging document between the analysis methods in the 270-301 protocol (version 
7.0, 15 July 2021; US-specific), the 2-year analysis SAP (version 2.0, 13 December 2021) and the 2-year 270-301 
CSR. 
The table below outlines all the changes made to the 2-year analysis methods, including primary and secondary 
endpoints  
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SURWRFRODSGI 3DJH

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SURWRFRODSGI 3DJH

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CLINICAL STUDY PROTOCOL AMENDMENT SUMMARY 
Amendment 7 (United States-Specific) 
Date: 15 July 2021 
RATIONALE AND SUMMARY OF CHANGES
A summary of major changes covered by Amendment 7 to the 270-
ocol is provided 
below.  
 
Rationale: The changes made include: 
 Including a targeted liver ultrasound at the End of Year visits for Year 2 through 
Year 
 
 
-
dy. 
Year-
While no cases of HCC have been reported in the Sponsor's AAV gene therapy non-clinical 
 
2. 
-
 
Rationale: 
purposes of 
expedited safety reporting and additional safety monitoring. 
3. Language around the statistical analysis of secondary endpoints and objective has been 
amended. 
Rationale: The efficacy evaluation period for analysis of the secondary endpoints 
-
d the 
timeframe of the study and allow for the possibility of producing one or more interim CSRs 
 

 
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Proprietary and Confidential 
 
 Language has been added concerning the use of the SARS-CoV-2 vaccines. 
Rationale: Due to the current worldwide SARS-CoV-2 pandemic and evolving availability 
and types of vaccines, language has been added to assist with timing and planning for 
assessment 
conducted on the currently available vaccines and guidance from multiple health agencies, 
and include information regarding different types of SARS-CoV-2 vaccines. 
5. The reactive corticosteroid regimen for ALT elevation has been updated. 
Rationale: The guidance for the reactive corticosteroid regimen, including management of 
ALT elevations and corticosteroid taper, reflects the data gathered from previous BMN 270 
studies. This change attempts to promote the safe and effective use of reactive 
corticosteroids.  
 
 
Rationale: Assessment of TGA to date in the BMN 270 development program has provided 
assessment helps to alleviate patient and site burden. If TGA assessments from 270-
-poor plasma samples may be 
utilized. 
7. The definition of treatment failure has been changed.  
Rationale: The previous defi
achieve FVIII activity 
 5 
these conditions to be present before a subject may be considered a treatment failure. The 
revision reflects the data seen as of the 52-
-
f 
 
 
-5 has been decreased. These 
changes include: 
 
-5 
Rationale: 
-term protein to activity ratios 
 Reducing AAV5 TAb to End of Year Visits only for Years 3-5 
Rationale: Antibody response is high and does not change much over time. Yearly 
testing should be sufficient to understand longer term responses, as little change is 
expected. 

 
270-
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Proprietary and Confidential 
 
 Reducing FVIII TAb to End of Year Visits only for Years 3-5 
Rationale: FVIII Bethesda Inhibitor is the main safety assessment. After 3 years, if 
plasma from another assay may be used for testing. 
 
Visit, a
 
Rationale: The most significant information from this assessment is obtained from 
baseline and samples collected shortly after dosing. As the TI remains high after 
nfusion. 
 Additional changes to the statistical analysis language have been made, including a new 
protocol appendix that outlines changes made specifically for analyses to be submitted in 
 
Rationale: The changes were made in 
the primary endpoint, with the primary efficacy assessment based on results through two 
years post-BMN 270 infusion follow-up for all subjects. 
Additional details on obtaining multiple biopsies as part of the liver biopsy substudy have 
been added. 
 The identity of the medical monitor has been updated. 
 Minor changes have been made for purposes of consistency and clarity. 
Refer to Section
 
 

 
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2
SYNOPSIS 
NAME OF COMPANY
BioMarin Pharmaceutical Inc.
 
 
 
 
BMN 270 
 
NAME OF ACTIVE INGREDIENT: 
AAV5-hFVIII-SQ
SUMMARY TABLE
Referring to Part of the 
Dossier: 
Volume:  
Page:  
Reference:  
FOR NATIONAL 
AUTHORITY USE 
ONLY: 
TITLE OF STUDY: 
A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of  BMN 270, an 
Adeno-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII in Hemophilia A 
 
PROTOCOL NUMBER: 
270-
 
STUDY SITES:
 
PHASE OF DEVELOPMENT: 
Phase 3 
STUDY RATIONALE: 
-
5,000 males.  It is caused by 
essential cofactor in the intrinsic coagulation pathway. This disorder can be either inherited, due to 
ties of 
FVIII or a dysfunctional FVIII, but all are characterized by a defective coagulation process.  
The clinical phenotype of HA patients generally correlates tightly with the level of residual 
expression. Severe HA is classified as FVIII activity less 
-
 
-5
-type activity and the mild form is 5-
The 
predominantly in joints and soft tissues, with 
hemorrhage when the brain is involved.  Subjects with moderate disease can exhibit manifestations 
similar to those seen in patients with severe HA, resulting in a comparable bleeding phenotype.   
Treatment of severe HA presently consists of intravenous injection of plasma-derived or 
-3 
and at the time of a bleed, to prevent or control bleeding episodes, respectively. The half-life for 
 
major advance in the treatment of HA, it remains common for severe HA patients to continue to 
have multiple bleeding events on pr
-
-
-demand-
.5-
-
 prospective 

 
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NAME OF COMPANY
BioMarin Pharmaceutical Inc.
 
 
 
 
BMN 270 
 
NAME OF ACTIVE INGREDIENT: 
AAV5-hFVIII-SQ
SUMMARY TABLE
Referring to Part of the 
Dossier: 
Volume:  
Page:  
Reference:  
FOR NATIONAL 
AUTHORITY USE 
ONLY: 
debilitating multiple-
f death. Chemical 
 FVIII-
-
promise in reduced dosing and maintaining activi
proportion of the dosing interval. However, patients with severe HA who are treated with extended 
half-life FVIII remain dependent on multiple infusions to maintain critical levels of FVIII activity. 
There is therefore a strong unmet need for a fully preventive treatment of HA to give patients a 
FVIII level compatible with a normal and hemorrhage-free life.  
Gene therapy offers the potential of disease-modifying therapy by continuous endogenous 
production of active FVIII following a single intravenous infusion of a vector encoding the 
-term episomal expression. Hemophilia A is well-suited for a 
a single 
regulated control of gene expression is not essential, and even modest increases in the level of 
ameliorate the severe form of hemophilia A.  Thus, relatively small changes in endogenous FVIII 
activity can result in clinically relevant improvements in disease phenotype. Finally, the circulating 
FVIII response to gene 
 
Several different gene transfer strategies for FVIII replacement have been evaluated, but 
adeno-ass
well-defined safety profile, and can direct long-term transgene expression with tropism and 
Indeed, an ongoing gene therapy clinical trial for a related disorder, hemophilia B, has established 
-
sufficient for conversion of their bleeding phenotype from severe to moderate or mild is achievable 
-
have been able to discontinue factor prophylaxis without suffering spontaneous hemorrhages, even 
 
BMN 270 is an AAV5-based gene therapy vector that expresses the SQ form of hFVIII under the 
control of a hybrid human liver-
Figure
 

 
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Proprietary and Confidential 
NAME OF COMPANY
BioMarin Pharmaceutical Inc.
BMN 270 
NAME OF ACTIVE INGREDIENT:
AAV5-hFVIII-SQ
SUMMARY TABLE
Referring to Part of the 
Dossier:
Volume:  
Page: 
Reference: 
FOR NATIONAL 
AUTHORITY USE 
ONLY:
Figure 1:  hFVIII-SQ Vector Genome and Encoded Protein
Legend –
BMN 270 will be delivered by a single intravenous dose and is designed to achieve stable, 
potentially life-long expression of active hFVIII in the plasma, synthesized from vector-transduced 
liver tissue. 
BMN 270 is being evaluated in clinical study 270-
-in-
escalation study in subjects with severe HA designed to assess the safety and efficacy of BMN 270 
-
explores the relationship of vector dose to the augmentation of residual FVIII activity and whether 
these levels are sufficient to alter the clinical phenotype. Four-year results from 270-
-
year results from 270-
, as measured by a chromogenic substrate assay, are 
acceptable safety profile. Preliminary results from optional liver biopsies confirm dose-dependent 
pan-lobular and otherwise healthy liver transduction at 2.7-
The current study is a Phase 3, single-arm, open-label study designed to assess whether, in an 
expanded sample, BMN 270 can safely alter the clinical phenotype of hemophilia A patients with 
residual FVII
OBJECTIVES: 
The primary efficacy objective of the study is to:
Assess the efficacy of BMN 270 defined as FVIII activity, as measured by chromogenic 
-52 following intravenous infusion of BMN 270

 
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NAME OF COMPANY
BioMarin Pharmaceutical Inc.
 
 
 
 
BMN 270 
 
NAME OF ACTIVE INGREDIENT: 
AAV5-hFVIII-SQ
SUMMARY TABLE
Referring to Part of the 
Dossier: 
Volume:  
Page:  
Reference:  
FOR NATIONAL 
AUTHORITY USE 
ONLY: 
The secondary efficacy objectives of the study are to:
 
Assess the impact of BMN 270 on usage of exogenous FVIII replacement therapy in the 
-year 
analysis, hereafter referred to a
 
 
 
The tertiary efficacy objective of the study is to: 
 
Assess the impact of BMN 270 on patient-
 52 of the 
study compared to baseline 
The safety objectives of the study are to: 
 
 
 
Assess the long-term safety of BMN 270 
The exploratory objectives of the liver biopsy substudy are: 
 
To examine the histopathology of the liver following BMN 270 therapy, including 
 
 
 
 
To determine which forms of rAAV vector DNA are present at the time of biopsy. 
 
-portal hepatocytes, 
central vein 
 
The aforementioned study efficacy objectives were achieved through the pre-specified analysis at 
-
-BMN 270 infu
Results from this analysis are intended to support regulatory submissions to EMA and other health 
authorities outside of FDA. 
-year safety and efficacy data on all subjects in 
270-
-
Appendix 2 has been created to specify region-
the associated endpoints and analyses to achieve them
-
 

 
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NAME OF COMPANY
BioMarin Pharmaceutical Inc.
BMN 270 
NAME OF ACTIVE INGREDIENT:
AAV5-hFVIII-SQ
SUMMARY TABLE
Referring to Part of the 
Dossier:
Volume:  
Page: 
Reference: 
FOR NATIONAL 
AUTHORITY USE 
ONLY:
STUDY DESIGN AND PLAN: 
This is a Phase 3, single-arm, open-label study in hemophilia A patients with residual FVIII levels 
treated continuously with prophylactic exogenous FVIII for a minimum of one year 
prior to enrollment
have high-
-documented historical data available concerning previous bleeding 
in the study. 
 270 as 
a single intravenous infusion. Approximately 20 subjects will enroll in the study with at least 
 months of well-documented high-
udy after having 
-sponsored non-interventional 
study 270-
collected.

 
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NAME OF COMPANY
BioMarin Pharmaceutical Inc.
 
 
 
 
BMN 270 
 
NAME OF ACTIVE INGREDIENT: 
AAV5-hFVIII-SQ
SUMMARY TABLE
Referring to Part of the 
Dossier: 
Volume:  
Page:  
Reference:  
FOR NATIONAL 
AUTHORITY USE 
ONLY: 
In order to minimize bias in the ongoing study and to assure safe and ethical conduct of the clinical 
statistics, and hemophilia, has been convened. The DMC will have sole access during the trial to 
amalgamated FVIII activity levels, FVIII usage, and bleeding data and review available safety and 
 
 
recommends a dosing modification, then additional subjects may be enrolled, up to a total of 
 subjects, at the new BMN 
 
 
-negative 
 
e discontinued study participation prior 
interim results and the totality of the data, the secondary interim analysis was deemed unnecessary. 
The DMC reviewed interim analysis results to assess the efficacy and safety profiles, whether the 
pre-
interventions in the BMN 270 studies based on the totality of the data.  
-year analysis for the study was performed after all subjects had been followed for 52 
post-BMN 270 infusion. A separate 2-
 
-BMN 
-year 
and the 2-year analyses, safety and efficacy will then continue to be assessed long-term in all 
subjects for a total of approximately 5 years. 
ctic FVIII 
 
infusion 
which endogenous production of FVIII following gene transfer is expected to be efficacious, based 
on earlier results. 
In subjects who experience recurring bleeding episodes, the Investigator and Medical Monitor will 
discuss whether to resume prior FVIII prophylaxis. 
 
prophylactic FVIII replacement therapy due to joint bleeding episodes, in the judgment of the 
or 
Sponsor-
-5. Subjects who are not 
-5 may receive a scheduled monthly follow-up 
  

 
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NAME OF COMPANY
BioMarin Pharmaceutical Inc.
 
 
 
 
BMN 270 
 
NAME OF ACTIVE INGREDIENT: 
AAV5-hFVIII-SQ
SUMMARY TABLE
Referring to Part of the 
Dossier: 
Volume:  
Page:  
Reference:  
FOR NATIONAL 
AUTHORITY USE 
ONLY: 
There will be an ongoing review of individual subject safety by the Medical Monitor, and both 
safety and efficacy data by the DMC. Therapeutic oral corticosteroids or other systemic 
immunosuppressive agents may be initiated when a subject’s ALT values are elevated, and 
ical 
Monitor. 
Any safety signal may trigger a review of the data and possible additional immunogenicity studies 
or other diagnostics deemed necessary that include an assessment of cellular immune responses 
using collected peripheral blood mononuclear cells 
 
-
-5 
following BMN 270 infusion. Subjects who consent to the liver biopsy will have additional 
assessments including a liver ultrasound and FibroScan, and will receive prophylactic FVIII prior 
Additional liver biopsies may be performed as part of the substudy during Years 2-5 as clinically 
indicated. 
NUMBER OF SUBJECTS PLANNED:  
 
DIAGNOSIS AND ALL CRITERIA FOR INCLUSION AND EXCLUSION:  
Patients are eligible to be included in the study only if all of the following criteria apply: 
 
 
evidenced by medical history, at the time of signing the informed consent.  
2. Must have been on 
 months prior to 
study entry.  High-
-documented historical data concerning bleeding episodes 
 
3. 
 exposure 
 
 Willing and able to provide written, signed informed consent after the nature of the study 
has been explained and prior to any study-related procedures. 
5. No previous documented history of a detectable FVIII inhibitor, and results from a 
 Bethesda 
 
 

 
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NAME OF COMPANY
BioMarin Pharmaceutical Inc.
 
 
 
 
BMN 270 
 
NAME OF ACTIVE INGREDIENT: 
AAV5-hFVIII-SQ
SUMMARY TABLE
Referring to Part of the 
Dossier: 
Volume:  
Page:  
Reference:  
FOR NATIONAL 
AUTHORITY USE 
ONLY: 
Sexually active participants must agree to use an acceptable method of effective 
contraception, either double-
contraceptives or having an intrauterine device. Participants must agree to contraception 
-
use only if they have had 3 consecutive semen samples with viral vector DNA below the 
limit of detection. 
7.
Willing to abstain from alcohol consumption for at least the first 52 
wing 
BMN 270 infusion. 
Patients are excluded from the study if any of the following criteria apply: 
 Detectable pre-existing antibodies to the AAV5 capsid. 
2. Any evidence of active infection or any immunosuppressive disorder, including HIV 
infection.  
3. Significant liver dysfunction with any of the following abnormal laboratory results: 
 
 
 
 
 
-
 
 
 
 
 
 
 
Subjects whose liver laboratory assessments fall outside of these ranges may undergo repeat 
testing of the entire liver test panel within the same Screening window and, if eligibility 
criteria are met on retest, may be enrolled after confirmation by the Medical Monitor.   
 
-
Batts-
 fibrosis if an 
alternative scale is used. 
5. Evidence of any bleeding disorder not related to hemophilia A. 
 
 
7. 
 

 
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NAME OF COMPANY
BioMarin Pharmaceutical Inc.
 
 
 
 
BMN 270 
 
NAME OF ACTIVE INGREDIENT: 
AAV5-hFVIII-SQ
SUMMARY TABLE
Referring to Part of the 
Dossier: 
Volume:  
Page:  
Reference:  
FOR NATIONAL 
AUTHORITY USE 
ONLY: 
Liver cirrhosis of any etiology as assessed by liver ultrasound.
Chronic or active hepatitis 
nterpretation of serological test results in the Laboratory Manual. 
 Active Hepatitis C as evidenced by detectable HCV RNA or currently on antiviral therapy.  
 Active malignancy, except non-
 
 History of hepatic malignancy. 
 History of art
non-
with the exception of catheter-associated thrombosis for which anti-thrombotic treatment 
is not currently ongoing.  
 
 
 Treatment with any investigational product within 30 days or 5 half-lives of the 
investigational product prior to the screening period. For subjects who have received a 
receiving that investigational product must have resolved prior to screening for this study. 
 Any condition that, in the opinion of the Investigator or Sponsor would prevent the patient 
interpretation of subject safety or efficacy result. 
 Prior treatment with any vector or gene transfer agent. 
 Major surgery planned in the 52-
 270. 
 
oids, or live vaccines 
within 30 days before the BMN 270 infusion. 
20. 
-
protocol or have the potential to impact the evaluation of efficacy and safety of BMN 270 
and with prior consultation with the Medical Monitor. 
 
 

 
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NAME OF COMPANY
BioMarin Pharmaceutical Inc.
 
 
 
 
BMN 270 
 
NAME OF ACTIVE INGREDIENT: 
AAV5-hFVIII-SQ
SUMMARY TABLE
Referring to Part of the 
Dossier: 
Volume:  
Page:  
Reference:  
FOR NATIONAL 
AUTHORITY USE 
ONLY: 
22.
bleeding episode.
Optional Liver Biopsy Substudy Inclusion and Exclusion Criteria 
Individuals eligible for the optional liver biopsy must meet the following inclusion criterion: 
 Able to sign informed cons
 
2. 
be treated with additional exogenous FVIII replacement products in order to increase their 
 
Individuals who meet any of the following exclusion criteria will not be eligible for the optional 
liver biopsy: 
 Any condition that, in the opinion of the Investigator or a hepatologist or radiologist, 
liver biopsy contraindicated. This includes 
abnormalities detected on liver ultrasound performed 
INVESTIGATIONAL PRODUCT(S), DOSE, ROUTE AND REGIMEN:  
 
infusion will depend on the subject’s weight. 
REFERENCE THERAPY(IES), DOSE, ROUTE AND REGIMEN:  
No reference therapy will be evaluated in this study. 
DURATION OF TREATMENT:  
BMN 270 is given as a single dose by intravenous infusion. 
CRITERIA FOR EVALUATION: 
Efficacy:  
Primary efficacy endpoint: 
 
Change of the hFVIII activity, as measured by chromogenic substrate assay, during 
 
-52 post-BMN 270 infusion from baseline. Each subject’s hFVIII activity during 
-
-
Values for hFVIII activity will be excluded if obtained within 72 hours since the last 
infusion of exogenous FVIII protein concentrates. 

 
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Secondary efficacy endpoints: 
 
 exogenous FVIII replacement therapy in 
the efficacy evaluati
of exogenous FVIII replacement therapy.  
 
“W
 
Tertiary efficacy endpoints: 
 
Change from baseline in the total score of Haemo-QoL-
 52 of the study 
post-BMN 270 infusion. 
 
Change from baseline in the EQ-5D-
-BMN 270 
infusion. 
 
 52 of the 
study post-BMN 270 infusion. 
 
ctivity Impairment plus Classroom 
 52 of the 
study post-BMN 270 infusion. 
 
 post-BMN 270 infusion. 
Safety: 
The following safety outcome measurements will be assessed: 
 
 
 
 
 
Change in vital signs 
 
Change in physical examination  
 
 
 
 
 
Immune response to FVIII transgene product and AAV5 capsid proteins 
Each subject will have comprehensive surveillance monitoring of LTs 
 -
 37-
LTs will be 
ng Years 3-5 post-dose in 
based on discussion 
  
There will be a detailed assessment of cellular and humoral responses to AAV5 capsid and FVIII 
protein.   
Pharmacodynamics: 
The FVIII protein concentration and activity level as measured by a validated immunoassay and a 
validated FVIII activity assay, respectively, will be use
activity will be used to determine PD parameters. 
 

 
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NAME OF COMPANY
BioMarin Pharmaceutical Inc.
 
 
 
 
BMN 270 
 
NAME OF ACTIVE INGREDIENT: 
AAV5-hFVIII-SQ
SUMMARY TABLE
Referring to Part of the 
Dossier: 
Volume:  
Page:  
Reference:  
FOR NATIONAL 
AUTHORITY USE 
ONLY: 
STATISTICAL METHODS:  
Sample Size 
for this study is based on clinical and statistical considerations in order to provide sufficient data to 
assess both safety and efficacy of BMN 270.  
-52 from baseline is greater than 0, assuming an 
-sample t-test with a 2-sided significance level of 0.05.  
For the secondary endpoints, the analyses will be performed utilizing exogenous FVIII use and 
-interventional study 270-
270-
efficacy ev
-sample t-test with a 2-sided significance level of 0.05. 
 the change in 
-
- and post-BMN 270 infusion population mean 
-sample t-test with a 2-sided significance level of 
demonstrate that the change is less than 0, ie, superiority of BMN 270 against FVIII prophylaxis. 
secondary efficacy endpoints hierarchically with a 2-sided significance level of 0.05. 
Analysis Population 
The intention-to-
 270 infusion, 
and the modified intention-to-
 270 
infusion and are HIV-negative. The mITT population will be used for the primary efficacy 
analysis, and the ITT population will be used for the supportive efficacy analysis. The ITT 
population will also be used for the safety analysis.  
Analysis 
 change in the hFVIII activity during 
 
-52 post-BMN 
a one-sample t-test will be used to test the null hypothesis that the change is 0 or less against the 

 
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NAME OF COMPANY
BioMarin Pharmaceutical Inc.
 
 
 
 
BMN 270 
 
NAME OF ACTIVE INGREDIENT: 
AAV5-hFVIII-SQ
SUMMARY TABLE
Referring to Part of the 
Dossier: 
Volume:  
Page:  
Reference:  
FOR NATIONAL 
AUTHORITY USE 
ONLY: 
alternative hypothesis that the change is greater than 0. Descriptive summaries of the proportions 
-
l also be provided.  
subjects in the mITT 
 months in the 
non-interventional study 270-
rollment in 270-
 
For the first-
hange in the annualized utilization 
 
-sample t-test will be performed to test the null hypothesis that the change is 0 or 
greater against the alternative hypothesis that the change is less than 0.  
For the second-
xogenous FVIII replacement treatment in the efficacy evaluation 
-sample t-test will be performed to test for non-inferiority of 
llected 
in 270-
against the alternative hypothesis that the change is less than 3.5. If non-inferiority is 
demonstrated, the test for superiority of BMN 270 against FVIII prophylaxis will be performed. 
The primary efficacy endpoint and secondary efficacy endpoints will be tested hierarchically 
according to the order described above.  
-negative subjects, 
 
results and the totality of the data, the secondary interim analysis was deemed unnecessary. The 
DMC reviewed the interim analysis results to assess the efficacy and safety profiles, whether the 
pre-
interventions in the BMN 270 studies based on the totality of the data. The primary efficacy 
endpoint for the interim analyses involves hFVIII activity, as measured by chromogenic substrate 
assay, achieved post-BMN 270 infusion, as detailed in the statistical analysi
 
 
, 
-
, and the 2-
 
analyses results, the study is planned to continue for a total of approximately 5 years upon the 
-year 
 and the 2-
, 
determined by the 
 

 
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NAME OF COMPANY
BioMarin Pharmaceutical Inc.
 
 
 
 
BMN 270 
 
NAME OF ACTIVE INGREDIENT: 
AAV5-hFVIII-SQ
SUMMARY TABLE
Referring to Part of the 
Dossier: 
Volume:  
Page:  
Reference:  
FOR NATIONAL 
AUTHORITY USE 
ONLY: 
analyses. 
The details of the interim analyses, including the control of Type I error rate, will be specified in 
the SAP. 
Analysis of safety endpoints will be primarily descriptive. The incidence of AEs will be 
summarized by system organ class, preferred term, relationship to study drug, seriousness, and 
severity. Clinical laboratory test values, vital signs, vector shedding and immune response 
parameters will be summarized descriptively by visit. 

 
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3
TABLE OF CONTENTS
Y ............................................2
2
SYNOPSIS...........................................................................................................................5
3
TABLE OF CONTENTS ...................................................................................................
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ....................................25
5
ETHICS..............................................................................................................................
Institutional Review Board or Independent Ethics Committee ................................
5.2
Ethical Conduct of Study ..........................................................................................
5.3
Subject Information and Informed Consent ..............................................................
INVESTIGATORS AND ST
 ........................30
7
 .............................................................................................................
Nonclinical Studies ...................................................................................................
7.2
Ongoing Clinical Studies ..........................................................................................32
7.3
Study Rationale .........................................................................................................32
Optional Liver Biopsy Substudy Rationale .................................................35
Benefits ...................................................................
 ..................................37
 ......................................................................................................
INVESTIGATIONAL PLAN ............................................................................................
Overall Study Design and Plan .................................................................................
Discussion of Study Design, Including Choice of Control Group ............................
Selection of Study Population ...................................................................................
Inclusion Criteria .........................................................................................
Exclusion Criteria ........................................................................................
Removal of Subjects from Treatment or Assessment .................................
Subject Identification and Replacement of Subjects ...................................
Duration of Subject Participation ................................................................
Treatments .................................................................................................................
Treatments Administered ............................................................................
Identity of Investigational Product ..............................................................

 
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Storage .........................................................................................................
Directions for Administration .....................................................................
Method of Assigning Subjects to Treatment Groups ..................................
 ...........................................................
Blinding .......................................................................................................
Prior and Concomitant Medications ............................................................70
Treatment Compliance ................................................................................
Investigational Product Accountability .....................................................................
Return and Disposition of Clinical Supplies ...............................................
Dietary or Other Protocol Restrictions......................................................................77
Safety and Efficacy Variables ...................................................................................77
Safety and Efficacy Measurements Assessed .............................................77
Primary Efficacy Variables .........................................................................77
Secondary Efficacy Variables .....................................................................
Tertiary Efficacy Variables .........................................................................
Immunogenicity ...........................................................................................
Pharmacodynamics ......................................................................................
Exploratory Assessments ............................................................................
Safety Variables ..........................................................................................
 REPORTING ADVERSE EVENTS .................................................................................
Safety Parameters and Definitions ............................................................................
Adverse Events ............................................................................................
Serious Adverse Events ............................................................................................
 ...............................................................
Methods and Timing for Capturing and Assessing Safety Parameters .....................
Adverse Event Reporting Period .................................................................
Eliciting Adverse Events .............................................................................
Assessment of Seriousness, Severity, and Causality ...................................
Procedures for Recording Adverse Events ...............................................................
Recording Adverse Events on an eCRF ......................................................
 ...........................................................................................

 
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 .............................................................
Institutional Review Board or Independent Ethics Committee 
..............................................................................
Follow-up of Subjects after Adverse Events .............................................................
Post-Study Adverse Events .......................................................................................
 ............................................................................................
BioMarin Pharmacovigilance Contact Information ................................................
APPROPRIATENESS OF M
 .............................................................
 
 .................................................................................................
Prestudy ...................................................................................................................
Screening Visit ........................................................................................................
 ........................................................................
Baseline Visit ..........................................................................................................
 ..................................................
BMN 270 Infusion Follow-
– 
-
 ..............................................
 .......................................................
– 
 .........................................................................................
– 
 .........................................................................................
 .............................................................................................................
 ..................................................................
 ................................................
 ..................................................................................
 
 ...............
 ......................................................
 ................................................................
 .......................................................................................
 .....................................................................................................
 ..................................................................................
Post-Infusion Follow-
– 
-52 ...............................................................
Every Visit .................................................................................................
 ....................................................................

 
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 ...................................
 ..........................................................................
 ..............................................................
 ..................................................................................
 .........................................................................................
 .....................................................................................................
Post-Infusion Follow-
– Years 2-5 .....................................................................
Year 2 – 
 ...................
Years 3-5 – 
 ...............
Years 2-5 – 
................................................................................................
Early Termination Visit ..........................................................................................
Optional Liver Biopsy .............................................................................................
End of Study ...........................................................................................................
 
CE ...................................................................................
 STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE ................
Statistical and Analytical Plans ...............................................................................
Interim Analyses ........................................................................................
 ........
Primary Efficacy Endpoint......................................................................................
Secondary Efficacy Endpoints ................................................................................
Liver Biopsy Substudy Analysis .............................................................................
Immunogenicity ......................................................................................................
Pharmacodynamic Analyses ...................................................................................
Safety Analysis .......................................................................................................
Determination of Sample Size ................................................................................
Analysis Populations ...............................................................................................
Changes in the Conduct of the Study or Planned Analyses ....................................
 DATA MONITORING COMMITTEE ...........................................................................
 COSTS, COMPENSATION, 
 ................................................
 CASE REPORT FORMS AN
 ............................................

 
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 ...................................................................
RETENTION OF RECORDS .........................................................................................
20
 .........................................................
 REFERENCES ................................................................................................................
22 INVESTIGATOR RESPONSIBILITIES ........................................................................
Conduct of Study and Protection of Human Patients .............................................
23
 .......................................................................................................
IA .........................................
25 
-S
IVES, ENDPOINTS, 
-YEA
 ................
Region-Specific Study Objectives ..........................................................................
25.2 Region-Specific Study Endpoints ...........................................................................
25.3 Statistical Methods for the Analysis of Region-Specific Endpoints .......................
Statistical Analysis Plan ............................................................................
25.3.2 Timing of Analysis ....................................................................................
25.3.3 Data to be Included in the Analysis ...........................................................
Analysis Populations .................................................................................
25.3.5 Interim Analyses and Control of Type I Error Rate ..................................
Analysis Methods ......................................................................................
 PROTOCOL AMENDMENT T
 ........................................................
LIST OF TABLES
Table 
– Screening and Infusion ....................................................
Table 
– Post-Infusion Follow-
-
 ............................
Table 
– Post-Infusion Follow-
-
 ..........................50
Table 
– Post-Infusion Follow-
– 
 .............53
Table 
– Post-Infusion Follow-
– 
 ....................
Table 
– Therapeutic Corticosteroids for ALT Elevations .............
Table 
– Optional Liver Biopsy .....................................................
Table 
 ..................
Table 
 .....................................................75

 
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Table 
 .............................................................................
Table
Liver Tests ....................................................................................................
Table
 ....................................................
Table 
Causality Attribution Guidance ..................................................................
LIST OF FIGURES
Figure 
-SQ Vector Genome and Encoded Protein .....................................................7
Figure 
hFVIII-SQ Vector Genome and Encoded Protein .............................................
Figure 
-
 .......................................................................................

 
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4
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS
AAV 
adeno-associated virus 
ABR 
annualized bleeding rate 
ADL 
activities of daily living 
ADR 
adverse drug reaction 
AE 
adverse event 
ALT 
alanine aminotransferase 
APTT 
activated partial thromboplastin time 
ART 
anti-retroviral therapy 
AST
aspartate aminotransferase
BPV 
BioMarin Pharmacovigilance 
 
 
CFR
Code of Federal Regulations
CRA 
clinical research associate 
CRF
case report form
CSR 
clinical study report 
CTCAE 
Common Terminology Criteria for Adverse Events 
DMC
Data Monitoring Committee
eCRF 
electronic case report form 
ED 
exposure days 
EOSI 
events of special interest 
ETV 
early termination visit 
EudraCT 
 
FDA
Food and Drug Administration
FIH 
first-in-human 
FVIII 
coagulation factor VIII 
GCP 
Good Clinical Practice 
GGT 
gamma-glutamyltransferase 
HA 
Hemophilia A 
HAL 
Haemophilia Activities List 
HBcAb 
hepatitis B core antibody 
HBsAb 
hepatitis B surface antibody 
HBsAg 
hepatitis B surface antigen
 
 
hFVIII
human coagulation factor VIII 
HIPAA 
Health Insurance Portability and Accountability Act 

 
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HLP
hybrid human liver-specific promoter
IB
investigator brochure
ICF 
informed consent form 
ICH 
 
ICH Ha
 
IEC 
independent ethics committee 
IND 
 
INR 
international normalized ratio 
IP 
investigational product 
IRB 
institutional review board 
ITT 
Intention-to-treat 
IV 
intravenous 
LT 
liver test 
MedDRA 
Medical Dictionary for Regulatory Activities 
mITT
Modified intention-to-treat 
MN 
mobile nursing 
PBMC
peripheral blood mononuclear cells
PCR
polymerase chain reaction
PD 
pharmacodynamics 
PEG
polyethylene glycol
 
 
PRO 
patient-reported outcome 
rhFVIII
recombinant human FVIII protein
REB
research ethics board
SAE
serious adverse event
SAP 
statistical analysis plan 
SDV 
source data verification 
SQ 
-
 
TGA 
thrombin generation assay 
 
upper limit of normal 
vg 
vector genomes 
VWF:Ag
von Willebrand factor Antigen
 
Impairment 
Questions: Hemophilia Specific

 
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Definition of Terms:  
“A pharmaceutical form of an active ingredient or placebo being tested or used as a reference 
tion when used or assembled 

 
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5
ETHICS
BioMari
studies according to the highest ethical and scientific standards. The following sections 
articulate standards to which Investigators will be held accountable, as well as matters of 
compliance to document adherence to such standards. 
5.1
Institutional Review Board or Independent Ethics Committee
during the course of the study. This includes, but is not limited to, providing appropriate 
documentation to support study initiation and maintaining appropriate flow of safety and 
other information during the course of the study and for study close-out activities. BioMarin 
st Investigators with access to timely and accurate information and 
 
Prior to initiating the study, the Investigator will obtain written confirmation that the 
with all appropriate material, including
information provided to the subjects, including all ICFs translated for patients who do not 
e clinical site. The study will not be initiated and Investigational 
recruitment materials are obtained in writing by the Investigator and copies are received at 
BioMarin or its designee. The approval document should refer to the study by protocol title 
 include 
the date of the review and approval. BioMarin will ensure that the appropriate reports on the 
accordance with applicable guidance documents and governmental regulations. 
5.2 
Ethical Conduct of Study
It is expected that Investigators understand and comply with the protocol. This includes, but 
is not limited to: establishing and meeting enrollment commitments, including providing 

 
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eligible subjects for study 
treatment administration and accountability. 
This study will be conducted in accordance with the following: 
 
 
 
ional and local regulations, as applicable 
 
experimentation 
pot
conducting the study do not find the hazards to outweigh the potential benefits. Each subject 
will provide written, informed consent before any study-related tests or evaluations are 
performed. 
5.3 
Subject Information and Informed Consent 
 
Clinical Tria
other applicable local regulations, will be obtained for each subject prior to entering the 
subject into the study. The Investigator will prepare the ICF and provide the documents to 
approved ICF, and if applicable, a copy of the approved subject information sheet and all 
ICFs translated to a language other than the native language of the clinical site must also be 
received by BioMarin or designee prior to any study-specific procedures being performed.
The Investigator will provide copies of the signed ICF to each subject and will maintain the 
original in the record file of the subject. 

 
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6
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE 
During administration of informed consent, expectations regarding participation in the study 
should be made clear to subjects. Patients who are 
with all aspects of the study should not be encouraged to participate. 
Prior to beginning the study, the Investigator at each site must provide to BioMarin or 
designee a fully executed and signed Statement of 
executed SOI on the form provided by the Sponsor.  All Investigators and Sub-Investigators 
also be completed for all Investigators and Sub-Investigators listed on the Form FDA 
SOI who will be directly involved in the treatment or evaluation of subjects in this study. 
The study will be administered by and monitored by employees or representatives of 
a periodic basis and perform verification of source documentation for each subject as well as 
In multicenter studies, a Coordinating Investigator will be identified who will be responsible 
and confirm that it accurately describes the conduct and results of the study, to the best of his 
participation in the study, ability to interpret data, and willingness to review and sign the 
report in a specified timeframe. The identity of the Coordinating Investigator and a list of all 
Investigators participating in the study will be provided in the CSR. 
Clinical Laboratory assessments will be performed at a nominated central laboratory. 
Bioanalytical samples will be sent to the appropriate specialty laboratories for testing. Refer 
to laboratory manual for more details.  

 
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7
INTRODUCTION 
-
 in 5,000 males 
codes for FVIII protein, an essential cofactor in the coagulation pathway. Clinical 
joints and soft tissues causing permanent disability and occasionally death mostly after brain 
hemorrhage. Treatment in Western countries 
 
 consists of intravenous 
injection of plasma-derived or recombinant FVIII protein concentrates at the time of a bleed 
to control it or prophylactically to prevent bleeding episodes. The short half-life for FVIII 
-
expensive for the majority of the world’s hemophilia A patients. These individuals develop 
life 
 
. Chemical modification or bioengineering of FVIII may improve 
half-
-
. However, these extended half-life FVIII variants do 
not eliminate the need for lifelong FVIII protein administration 
 
.  
Gene therapy offers the potential of disease-modifying therapy by continuous endogenous 
of vector. Hemophilia 
A is well-suited for this approach because its clinical manifestations are attributable to the 
-200 
plasma. Tightly regulated control of gene expression is not essential, and a modest increase 
ameliorate the severe phenotype 
therapy is a modest increase in hFVI
in most clinical laboratories. 
BMN 270 contains the cDNA for the B-domain-deleted SQ FVIII with a liver-specific HLP 
transcription promoter. The expression cassette is inserted between AAV2 ITRs, and this 
 270 is contained 
in the IB supplied by BioMarin. Investigators are to review this document prior to initiating 
this study. 
7.1 
Nonclinical Studies 
The nonclinical program supports a single IV infusion of BMN 270, the planned clinical 
route of administration, for the treatment of hemophilia A in male patients. This nonclinical 
ccount the guidelines and reflection papers for gene therapy medicinal 
products under EMA Advanced Therapies as well as FDA guidance. The primary 

 
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 270 were 
characterized in a series of single dose studies in species that were vector permissive and 
responsive to the transgene including normal CD-
- and T-cell deficient mouse 
-F8tm1Kaz
-Rag2tm1Fwa
and normal cynomolgus 
immunogenicity and toxicity endpoints. 
Results of the nonclinical program to date are detailed in the IB supplied by BioMarin.  
Investigators are to review this document prior to initiating this study. 
7.2 
Ongoing Clinical Studies 
Ongoing clinical studies for BMN 270 include: 
 270-
-escalation study in patients with severe HA 
 270-203, a phase 2 study in patients with severe HA who have anti-AAV5 antibody 
titers 
 270-
2 study in patients with severe HA who have active or prior FVIII 
inhibitors 
 270-302, a phase 3 study in patients with severe HA who receive BMN 270 at the 
 
 270-303, a phase 3 study in patients with severe HA who received BMN 270 at the 
A comprehensive review of safety, efficacy, and immunogenicity results as of the latest data 
cut is contained in the IB supplied by BioMarin. Investigators are to review this document 
prior to initiating this study. 
7.3 
Study Rationale 
-
 in 5,000 
an essential cofactor in the intrinsic coagulation pathway. This disorder can be either 
defective coagulation process.  The clinical phenotype of HA patients generally correlates 
tightly with the level of residual expression. Severe HA is classified as FVIII activity less 
-
-type activity and 
the mild form is 5-
spontaneous bleeding episodes, predominantly in joints and soft tissues, with a substantially 
ts with moderate 

 
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disease can exhibit manifestations similar to those seen in patients with severe HA, resulting 
in a comparable bleeding phenotype.   
Treatment of severe HA presently consists of intravenous injection of plasma derived or 
recombinant human 
-3 times per 
The half-
 
infusions, and although a major advance in the treatment of HA, it remains common for 
severe HA patients to continue to have multiple bleeding events on prophylactic therapy 
-
obse
-
-demand-
-
-
 prospective FVIII interventional 
multiple-
eg, 
ngineering of FVIII 
eg, FVIII-
-
proportion of the dosing interval. However, these extended half-life FVIII variants remain 
dependent on multiple infusions to maintain critical levels of FVIII activity in severe HA 
patients. There is therefore a strong unmet need for a fully preventive treatment of HA to 
give patients a FVIII level compatible with a normal and hemorrhage-free life.  
Gene therapy offers the potential of disease-modifying therapy by continuous endogenous 
production of active FVIII following a single intravenous infusion of a vector encoding the 
-term episomal expression. Hemophilia A is well-suited 
 
Tightly regulated control of gene expression is not essential, and even modest increases in 
any increase of the plasma level by 2 
endogenous FVIII activity can result in clinically relevant improvements in disease 
phenotype. Finally, the circulating FVIII response to gene transduction can be assessed using 
established laboratory tec
 
Several different gene transfer strategies for FVIII replacement have been evaluated, but 
adeno-
well-defined safety profile, and can direct long term transgene expression with tropism and 

 
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 among 
 Indeed, an on-going gene therapy clinical trial for a related disorder, hemophilia B, 
-
moderate or mild is achievable following a single peripheral vein infusion 
-
vector. Several participants in this trial have been able to discontinue factor prophylaxis 
previously resulted in bleeding. Thus, gene therapy treatment has resulted in a substantial 
improvement i
BMN 270 is an AAV5-based gene therapy vector that expresses the SQ form of hFVIII under 
the control of a hybrid human liver-
Figure 
Figure 7.3.1:  hFVIII-SQ Vector Genome and Encoded Protein
Legend –
BMN 270 will be delivered by a single intravenous dose and is designed to achieve stable, 
potentially life-long expression of active hFVIII in the plasma, synthesized from vector-
transduced liver tissue.  
BMN 270 is being evaluated in clinical study 270-
-in-
dose escalation study in subjects with severe HA designed to assess the safety and efficacy of 
BMN 27
Specifically, 270-
FVIII activity and whether these levels are sufficient to alter the clinical phenotype. Four-
year results from 270-
g of BMN 270, with an 

 
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receiving lower doses of BMN 270 in 270-
-dependent pan-lobular and 
otherwise healthy liver transduction at 2.7-
 additional information on 
preliminary data in 270-
 
The current study is a Phase 3, single-arm, open-label study designed to assess whether, in an 
expanded sample, BMN 270 can safely alter the clinical phenotype of hemophilia A patients 
 
7.3.1 Optional Liver Biopsy Substudy Rationale 
The usual pattern of response in hFVIII activity observed so far after administration of 
BMN 
 
-
-treatment 
followed by a decline to a steady-state level of expression thereafter. One of the explanations 
DNA degradation and repair, annealing, and circularization that can result in the formation of 
stable, double-stranded, circularized transgene DNA forms. It is these circularized DNA 
species that are thought to be associated with long-term, persistent expression of the gene 
product in target cells. Examination of transduced hepatocytes from subjects treated with 
BMN 270 in the 270-
and could account for the long-term hFVIII expression observed in humans. 
Additionally, health of the liver after gene transduction has been monitored indirectly by 
periodic assessments of hepatic enzymes released into the blood stream. Transient, post-
treatment elevations in ALT levels have been observed in the majority of subjects, as well as 
inter-subject variability in post-therapy FVIII activity levels. Neither the reasons for nor the 
significance of the ALT elevations or the variations in response to FVIII gene therapy are 
ue structure and function are also 
trials for hemophilia has been issued by medical and scientific leaders in the field to help 
 
 
The purpose of this exploratory substudy is to provide a better understanding of the long-
term gene expression related to genome circularization, health of the liver, and variation in 
FVIII activity levels observed after gene therapy with BMN 270. With use of prophylactic 
corticosteroids, it is believed that there will be stable hepatic function and FVIII activity 
thromboembolism. This substudy aims to evaluate the effect on the liver by performing liver 
biopsies 
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7.4 
Summary of Overall Risks and Benefits 
BMN 270 has an acceptable safety and tolerability profile that supports a positive 
benefit-
subjects across all investigated doses. All subjects have successfully completed their 
full-dose infusion of BMN 270, with 
completion due to AEs. No deaths have been reported in any of the BMN 270 studies, and no 
decreased over time with no delayed adverse drug reactions.  
Infusion reactions associated with BMN 270 administration included symptoms such as 
maculopapular rash, urticaria, nausea, diarrhea, watery eyes, rigors, chills, myalgia, fever, 
tachycardia and hypotension emerging wi
Infusion-related reactions were effectively mitigated by managing infusion rate and 
medications. 
Transient, asymptomatic 
suggestive of clinically significant hepatocyte injury or liver dysfunction. Across the 
 
-
-
-
elevation about 5.5 
-
 
than subjects in 270-
-
-
difference in the protocol-specified corticosteroid regimens in place in those studies, 
inclu
-
majority of ALT elevations responded rapidly to corticosteroids, given current interest in the 
field of AAV gene therapy for the use of non-steroidal approaches to managing or preventing 
ALT elevations, alternate non-steroidal systemic immunosuppressive agents have also been 
used to manage hepatic reactions where corticosteroids have proven to be ineffective or 
 have led to unwanted side 
effects. Overall, the literature and clinical experience with BMN 270 suggests that transient 
elevations in liver enzymes are expected following AAV-based gene therapy for the 
treatment for hemophilia A or B without any long-term concerns of hepatic injury 
Manno 
 
At the highest dose tested in 270-
-infusion.  Subjects in that cohort also reported 

 
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-study rates and the ability to discontinue 
prophylactic FVIII infusions. Subjects at all dose levels continue to be followed.  
In 270-
ity in the majority of subjects 
-
bleeding compared with pre-study rates and the ability to discontinue prophylactic FVIII 
-year analysis have been dosed with 
 
BMN 
clinical 
Each subject in 270-
onitors LTs 
during the study, and elevations in LTs will be addressed according to the guidelines set forth 
in the protocol. Safety will be assessed by adverse event reporting and clinical laboratory 
assessments.
For additional information on the 
current version of the Investigator’s Brochure. 
7.4.1 Optional Liver Biopsy Substudy Risks and Benefits 
Liver biopsy is considered a safe procedure, with serious complications occurring less than 
once in
complications are extremely small, the main complications would include bleeding and bile 
 
The most common problems include mild pain and a minor decrease in blood pressure. More 
serious complications, such as bleeding, infection, and injury to nearby organs, are very rare, 
but the subject will be monitored appropriately to ensure correct management should any of 
these occur. Any complications related to the liver biopsy should be reported as adverse 
events, as outlined in Section 
. The liver biopsy is a standard investigation, and will be 
explained more fully by the experienced clinician performing the biopsy.  
Each subject who participates in this optional substudy will have a comprehensive 
pre-
-biopsy surveillance plan according to the standard procedures at the institution. 
-5. Safety will 
be assessed by adverse event reporting and clinical laboratory assessments. Per the 

 
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would not be considered a hospitalization 
There is no direct benefit from participating in this study other than contributing to 
understanding the mechanism of action of BMN 270. Consenting into this specific substudy 
is optional and will not have any effect on the subject’s continued participation in 270-

 
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8
STUDY OBJECTIVES 
The primary efficacy objective of the study is to: 
 Assess the efficacy of BMN 270 defined as FVIII activity, as measured by 
 
-52 following intravenous infusion of 
BMN 270 
The secondary efficacy objectives of the study are to: 
 Assess the impact of BMN 270 on usage of exogenous FVIII replacement therapy in 
-
 
 Assess the impact of BMN 270 on the number of 
 
The tertiary efficacy objective of the study is to: 
 Assess the impact of BMN 270 on patient-
 52 of 
the study compared to baseline 
The safety objectives of the study are to: 
 Evaluate the safety of BMN 270 during the first 52 
infusion  
 Assess the long-term safety of BMN 270 
The exploratory objectives of the liver biopsy substudy are: 
 To examine the histopathology of the liver following BMN 270 therapy, including 
 
 
 
 To determine which forms of rAAV vector DNA are present at the time of biopsy. 
 
-portal 
 
The aforementioned study efficacy objectives were achieved through the pre-specified 
-
-
ded to support regulatory 
submissions to EMA and other health authorities outside of FDA.  

 
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-year safety and efficacy data on all subjects in 
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is regulatory 
-specific study objectives for the 
-
have withdrawn from the study. 
 

 
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9
INVESTIGATIONAL PLAN 
9.1 
Overall Study Design and Plan
This is a Phase 3, single-arm, open-label study in hemophilia A patients with residual FVIII 
 treated continuously with prophylactic exogenous FVIII for a minimum of 
one year prior to enrollment
 sites worldwide.  
Subjects must have high-
-documented historical data available concerning 
previous ble
 months in order 
to be eligible to enroll in the study. 
 
BMN 270 as a single intravenous infusion. Approximately 20 subjects will enroll in the study 
-documented high-
 subjects will enroll 
in the study after having completed ap
BioMarin-sponsored non-interventional study 270-
 in which bleeding and FVIII use data 
prior to gene therapy will be prospectively collected Figure 
.
. 
Figure 9.1.1:  Study 270-301 Design 
In order to minimize bias in the ongoing study and to assure safe and ethical conduct of the 
clinical trial, an 
clinical trials, statistics, and hemophilia, has been convened. The DMC will have sole access 
during the trial to amalgamated FVIII activity levels, FVIII usage, and bleeding data and will 
 
erent dose of BMN 270, 
 

 
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 subjects, at the new BMN 270 
 
 
HIV-
 
analysis was performed as planned in 
analysis was deemed unnecessary. The DMC reviewed interim analysis results to assess the 
efficacy and safety profiles, whether the pre-specified criteria of statistical significance has 
on the totality of the data.  
-year analysis for the study was performed after all subjects had been followed for 
52 
-BMN 270 infusion. A separate 2-year analysis will also be performed per 
-BMN 270 
-year and the 2-year analyses, safety and efficacy will then continue to 
be assessed long-term in all subjects for a total of approximately 5 years. 
 
 270. 
represents the time by which endogenous production of FVIII following gene transfer is 
expected to be efficacious, based on earlier results. 
As the relationship between activity assay results of the BMN 270 gene product and bleeding 
remains to be established, Investigators should strive to minimize bias by avoiding 
consideration of FVIII activity levels by themselves or subjects in the reporting of bleeding 
episodes and FVIII usage. 
In subjects who experience recurrent bleeding episodes, the Investigator and Medical 
Monitor will discuss whether to resume prior FVIII prophylaxis. 
independence from prophylactic FVIII replacement therapy due to joint bleeding episodes, in 
with the Medical Monitor or Sponsor-designated Data Monitor, follow an abbreviated visit 
 
during Years 2-5. 
-5 may 
receive a scheduled monthly follow-up telephone call from the sit
  

 
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There will be an ongoing review of individual subject safety by the Medical Monitor, and 
both safety and efficacy data by the DMC. Therapeutic oral corticosteroids or other 
immunosuppressive agents may be initiated when a subject’s ALT values are elevated, and 
Medical Monitor. Management of ALT elevations is discussed in more detail in 
Section
. 
Any safety signal may trigger a review of the data and possible additional immunogenicity 
studies or other diagnostics deemed necessary that include an assessment of cellular immune 
 
who consent to do 
-
 
Years 2-5 following BMN 270 infusion. Subjects who consent to the liver biopsy will have 
additional assessments, including a liver ultrasound and FibroScan, and will receive 
prophylactic FVIII prior to the procedure, as indicated in the judgment of the Investigator, to 
substudy during Years 2-5 as clinically indicated. 
Schedules of assessments for the 
Table 
-Infusion 
follow-
Table
, Table 
, Table 
, Table 
Table 
Table 
below. 
 

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Table 9.1.1:  Schedule of Events – Screening and Infusion 
Assessment 
Prior to BMN 270 Infusion
BMN 270 
Infusion Visit 
(Day 1)k 
Screening* 
(Day -28 to Day -1) 
Smart Rescreeningi  
(Day -28 to Day -1) 
Baseline (Day -7 
to Day -1)h
Informed consent 
 
 
 
 
Medical History
Physical Examinationa 
 
 
 
 
Height and Weight
Vital Signs
Assessment of Adverse Events and Concomitant Medications 
 
 
 
 
 
 
 
 
 
Distribution of subject diaries and training in their usel 
 
 
 
 
Electrocardiogram
hFVIII Assaysb 
j
AAV5 TAb Assaysc
AAV5 TI Assay
Screen for Hepatitis B, Hepatitis C, HIVd
Blood chemistry, hematology, and coagulation testse 
 
 
 
 
 
e 
Liver Testse 
determination of AAV5 and FVIII specific 
 
 
 
 
 

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Assessment 
Prior to BMN 270 Infusion
BMN 270 
Infusion Visit 
(Day 1)k 
Screening* 
(Day -28 to Day -1) 
Smart Rescreeningi
(Day -28 to Day -1) 
Baseline (Day -7 
to Day -1)h
 
 
 
 
 
TGA Assayg 
 
 
 
 
PCR of vector DNA in blood, saliva, urine, semen, and stools 
f 
 
 
 
 
g 
 
 
 
 
Haemo-QOL-A assessment
EQ-5D-5L  
 
 
 
 
HAL
PROBE 
 
 
 
 
BMN 270 Infusion
Hypersensitivity blood assessmentsm
m
BMN
a Complete physical examination should be done at Screening.  Brief physical examination may be done at Baseline and at the BMN 270 Infusion Visit.
b Includes baseline FVIII
-
 hours after last dose of replacement FVIII 
-
c Sample collection on the day of the infusion visit must be performed before the BMN 270 infusion is given. Screening, Smart Re-screening, and Infusion Day samples will be tested in an 
AAV5 TAb pre-screening assay specifically developed for enrolment purposes. Baseline and all post-dose samples will be tested in a different AAV5 TAb post-dose immunogenicity 
monitoring assay
d Patients with documented negative results within the last 30 days do not need to be retested. Hepatitis B screening should include hep
e Refer to Table
for laboratory assessments to be included, and to Table
. for liver tests. ABO blood typing assessment should be performed at Baseline, or at another 
regularly scheduled visit prior to the end of the subject’s participation in the study.
f Includes HLA genotyping and FVIII genotyping.

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g
assays used for these evaluations.  Subjects may choose to opt out of 
associated with hemophilia A. While exploratory samples will be collected at the time points indicated above, testing of thes
uding those for TGA assay and any other 
 
h Should the screening visit occur within 30 days of the drug infusion, physical examination, blood chemistry, LTs, hematology, urine tests, and coagulation tests do not need to be repeated 
at Baseline. 
i Smart rescreening should only be performed if a patient has been determined to be eligible for the study and is unable to complete the Baseline assessments and Infusion prior to the closing 
of the original Screening window.  
igning the original 
consent.  Subject
 days will be 
-consent and undergo all screening procedures.  Subjects may not undergo smart rescreening more than 
once. 
j 
 
 With the exception of the collection of samples for PCR vector DNA analysis, assessments on the day of infusion must be performed prior to the infusion.  Subjects will fast for at least 
 hours prior to pre-infusion laboratory sampling on the day of the infusion visit.  On the day of the BMN 270 Infusion, vital signs will be monitored prior to the infusion, during the 
 5 
ding samples for PCR of vector 
leted. 
l Diaries should be distributed to subjects who have consented to participate in the study and who have been determined to meet all study eligibility criteria. 
mIn case of hypersensitivity or adverse drug reaction, safety assessment, including physical examination and vital signs, will be done and additional blood samples will be collected within
 
-2
-patient observation can be extended and additional blood samples can be collected if deemed necessary at the discretion of the 
Investigator and Medical Monitor.

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Table 9.1.2:  Schedule of Events – Post-Infusion Follow-Up (Week 1-16) 
Assessment
Follow-Up After BMN 270 Infusion – Weeks*
Week 1 
2 
3 
4 
5g 
6
7g 
8 
9g 
10
11g 
12 
13g 
14 
15g 
16 
D4 
D8 
Study Day* 
 
 
 
22 
 
 
 
50 
57 
 
 
 
 
 
 
 
 
Physical examinationa
g 
g 
g 
g
g 
g 
Weighta
Assessment of Adverse 
Events and Concomitant 
review of subject diary for 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vital Signs
g 
 
g 
g 
g 
g 
g 
Blood chemistry, 
hematology, and 
coagulation testsb
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
b 
Liver Testsb
FVIII assaysc
FVIII antibody titer
PCR of vector DNA in 
blood, saliva, urine, semen, 
and stoolsd
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
assessmentse
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Haemo-QOL-A assessment
EQ-5D-5L
HAL

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Assessment
Follow-Up After BMN 270 Infusion – Weeks*
Week 1 
2 
3 
4 
5g 
6
7g 
8 
9g 
10
11g 
12 
13g 
14 
15g 
16 
D4 
D8 
Study Day* 
 
 
 
22 
 
 
 
50 
57 
 
 
 
 
 
 
 
 
PROBE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AAV5 TAb Assay
AAV5 TI Assay 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Testing for reactivation of 
hepatitis B and hepatitis C 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
f 
determination of AAV5 and 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VWF:Ag 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
* 
 
 
a
b Refer to Table
for laboratory assessments to be included, and to Table
.
values are  
 
 be monitored at least twice 
baseline value during the study and either an alternative etiology considered or for further 
evaluation of the lab abnormality may undergo a
iscretion of the 
ased on a review of subject data. If 
v
ssion between the Medical Monitor and the Investigator.
c 
-
exploratory assay, and hFVIII protein assay. If a subject has used FVIII within 72 hours of a measurement day, all efforts should be made to obtain FVIII activity measurements when a 
72-
-hour wash-
270 infusion and who 
have not resumed FVIII replacement therapy. 
n discussion 
between the Medical Monitor and the Investigator. A D-dimer may be considered under circumstances in which 
there is a concern for a venous thromboembolism.  
d Collection for each matrix to occur until at least 3 consecutive results below the limit of detection are obtained. Collection and testing of semen samples must continue at least through 
 
 consecutive results below the limit of detection in that compartment have already been recorded.  

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e Blood samples will be collected to evaluate biochemical, molecular, cellular, and
assays used for these evaluations. 
associated with hemophilia A. While exploratory samples will be collected at the time points indicated above, testing of thes
only as deemed necessary by the Sponsor. 
f 
r hepatitis C prior to study entry, should be performed only in 
subjects who have not received therapeutic oral 
 
oral corticosteroids will have hepatitis B and hepatitis C testing at 
the time points indicated in Table 
. 
g For subjects who have entered 270-
-
shortened lab draw-only visit. The MN service or site will collect blood samples at these visits. For site lab draw-only visits, sites will contact the subject via phone call or e-mail to collect 
information regarding adverse events, changes to concomitant medications, bleeding episodes, and FVIII use. For MN visits, the service will collect this information. The physical 
examination and vital signs assessments listed in the Schedule of Events will not be performed at these MN or lab draw-only visits for subjects who have entered 270-
participation in 270-
 a lab-only visit or MN visit can be conducted within the visit window, the site should telephone the subject to collect adverse event, 

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Table 9.1.3:  Schedule of Events – Post-Infusion Follow-Up (Week 17-32) 
Assessment 
Follow-Up After BMN 270 Infusion – Weeks*
17f 
18 
19f 
20
21f 
22 
23f 
24 
25f 
26 
27f 
28
29f 
30f 
31f 
32
Study Day*
225
Physical examinationa 
f 
 
f 
 
f 
 
f 
 
f 
 
f 
 
f
f 
f 
 
Weighta
Assessment of Adverse 
Events and 
Concomitant 
review of subject diary 
for bleeding and FVIII 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vital Signs 
f 
 
f 
 
f 
 
f 
 
f 
 
f 
 
f
f 
f 
 
Blood chemistry, 
hematology, and 
coagulation testsb     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
b 
Liver Testsb 
FVIII assaysc
FVIII antibody titer
PCR of vector DNA in 
blood, saliva, urine, 
semen, and stoolsd
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
assessmentse
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Haemo-QOL-A 
assessment
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Assessment 
Follow-Up After BMN 270 Infusion – Weeks*
17f 
18 
19f 
20
21f 
22 
23f 
24 
25f 
26 
27f 
28
29f 
30f 
31f 
32
Study Day*
225
HAL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PROBE
AAV5 TAb Assay 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AAV5 TI Assay
determination of AAV5 
and FVIII specific 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VWF:Ag 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TGA Assaye
Optional liver biopsyg 
*
.  
a
b Refer to Table
for laboratory assessments to be included, and to Table
.
values are 
but LTs will be monitored at least twice 
baseline value during the study and either an alternative etiology considered or for further 
evaluation of the lab abnorm
ased on a review of subject data.  If FVIII 
ussion between the Medical Monitor and the Investigator.
c 
FVIII assay and one-
exploratory assay, and hFVIII protein. If a subject has used FVIII within 72 hours of a measurement day, all efforts should be made to obtain FVIII activity measurements when a 72-hour 
-hour wash-
not resumed FVIII replacement therapy. 
n discussion between 

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the Medical Monitor and the Investigator. A D-dimer may be considered under circumsta
concern for a venous thromboembolism.  
d Collection for each matrix to occur until at least 3 consecutive results below the limit of detection are obtained. 
e 
assays used for these evaluations.  Subjects may choose to 
 
associated with hemophilia A. While exploratory samples will be collected at the time points indicated above, testing of these sa
 
f For subjects who have entered 270-
-
ject has given written informed consent to participate in 
the site as a shortened lab draw-only visit. The MN service or site will collect blood samples at these visits. For site lab draw-only visits, sites will contact the subject via 
phone call or e-mail to collect information regarding adverse events, changes to concomitant medications, bleeding episodes, and FVIII use. For MN visits, the service will collect this 
information. The physical examination and vital signs assessments listed in the Schedule of Events will not be performed at these MN or lab draw-only visits for subjects who have entered 
270-
-
-only visit or MN visit can be conducted within the visit window, the site should telephone the subject to collect 
adverse event, concomitant m
 
g Subjects who elect to proceed will have a liver biopsy performed 
-infusion
time 
he study. 
 hours prior 
to liver ultrasound and optional liver biopsies. 
 

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Table 9.1.4:  Schedule of Events – Post-Infusion Follow-Up (Week 33 – Week 52) 
Assessment 
Year 1 – Weeks*
33f 
34e 
35f 
36 
38f 
40 
42f 
44 
46f
48
50f 
52
Study Day*
232
253
323
337
Physical examinationa 
 f 
 f 
 f 
 
 f 
 
 f 
 
 f 
 
 f 
 
Weighta
Assessment of Adverse Events and Concomitant Medications 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vital Signs
 f
 f
 f
 f
 f
 f
 f
Blood chemistry, hematology, and coagulation testsb
b 
 
 
 
 
 
 
 
 
 
 
 
 
Liver Testsb 
FVIII assaysc
AAV5 TAb Assay 
 
 
 
 
 
 
 
 
 
 
 
 
AAV5 TI Assay
FVIII antibody titer 
 
 
 
 
 
 
 
 
 
 
 
 
d
 
 
 
 
 
 
 
 
 
 
 
 
 
VWF:Ag
TGA Assayd
PCR of vector DNA in blood, saliva, urine, semen, and stoolse
Haemo-QOL-A assessment
EQ-5D-5L
HAL
PROBE

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Assessment 
Year 1 – Weeks*
33f 
34e 
35f 
36 
38f 
40 
42f 
44 
46f
48
50f 
52
Optional liver biopsyg
*
a 
thr
b Refer to Table
for laboratory assessments to be included, and to Table
.
are  
  
baseline value during the study and either an alternative etiology considered or for further 
Investigator. Additional testing of FVIII and LTs durin
between the Medical Monitor and the Investigator based on a 
review of subject data. If 
e adjusted based on discussion 
between the Medical Monitor and the Investigator. 
c 
-
exploratory assay, and hFVIII protein assay. If a subject has used FVIII within 72 hours of a measurement day, all efforts should be made to obtain FVIII activity measurements when a 
72-
-hour wash-out period is only intended for subjects who 
 
 270 infusion and who 
have not resumed FVIII replacement therapy. 
n discussion 
between the Medical Monitor and the Investigator. A D-
 
there is a concern for a venous thromboembolism. 
d Blood samples will be col
r AAV gene transfer, and to develop 
assays used for these evaluations.  
associated with hemophilia A. While exploratory samples will be collected at the time points indicated above, testing of thes
and any other 
 
e Collection for each matrix to occur until at least 3 consecutive results below the limit of detection are obtained.
f For subjects who have entered 270-
following participation in 270-
site as a shortened lab draw-only visit. The MN service or site will collect blood samples at these visits. For site lab draw-only visits, sites will contact the subject via phone call or e-mail 
to collect information regarding adverse events, changes to concomitant medications, bleeding episodes, and FVIII use. For MN visits, the service will collect this information. 
The physical examination and vital signs assessments listed in the Schedule of Events will not be performed at these MN or lab draw-only visits for subjects who have entered 270-
following participation in 270-
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g Subjects who elect to proceed will have a liver biopsy performed 
-
. Additional liver biopsies at times deemed to be clinically relevant 
 
r biopsy performed during the study. Subjects should fast 
 hours prior to liver ultrasound and optional liver biopsies. 
 

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Table 9.1.5:  Schedule of Events – Post-Infusion Follow-Up (Year 2 – Year 5) 
Assessment 
Years 2-5*
Year 2*
Years 3-5*
End of Year Visit
ETV 
Q12W 
Q4Wj 
Q6Wj 
Year 2 
Year 3 
Year 4 
Year 5 
Study Week*
Physical examinationa 
a 
 
 
a 
 
Weighta
a
a
Assessment of Adverse Events and Concomitant Medications 
 
 
 
 
 
 
Vital Signs
Blood chemistry, hematology, and coagulation testsb
b 
b 
b 
 
 
 
 
Liver Testsb 
FVIII assaysc
FVIII protein assay 
 
 
 
 
 
AAV5 TAb Assayd
d
FVIII antibody titerd 
d 
 
 
 
 
AAV5 TI Assaye 
e 
e 
 
 
 
 
 
 
VWF:Ag
PCR of vector DNA in semenf
f
f
f
f
f
PCR of vector DNA in blood, saliva, urine, and stoolsf
f
f
f
g
Haemo-QOL-A assessment
h 
h
EQ-5D-5L
h
h
HAL
h
h
h
h

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Assessment 
Years 2-5*
Year 2*
Years 3-5*
End of Year Visit
ETV 
Q12W 
Q4Wj 
Q6Wj 
Year 2 
Year 3 
Year 4 
Year 5 
Study Week*
PROBE 
h 
 
 
h 
 
Liver ultrasoundi 
 
 
 
 
 
Optional liver biopsy
ETV: Early Termination Visit
* 
-
 3-
during Years 2-5 cannot be done by a MN professional and must be done at the study site. 
a Complete physical examination should be performed 
sits. 
Weight should be recorded 
 during Years 2-5.
b Refer to Table 
 for laboratory assessments to be included, and to Table 
.  
 
 
baseline value or based upon discussion between the Medical Monitor and the Investigator. Subjects with ALT 
baseline value during the study and either an 
ging studies including MRI or ultrasound, additional blood 
 
 
nvestigator based on a review of subject data. If ALT values are stable over 
cal Monitor and the Investigator. During Years 2-5 of the 
Post-Infusion Follow-
 at every End of Year visit.
c 
-st
coagulation exploratory assay. If a subject has used FVIII within 72 hours of a measurement day, all efforts should be made to obtain FVIII activity measurements when a 72-hour interval 
-hour wash-
270 infusion and who have not 
resumed FVIII replacement therapy. If FVIII leve
between the 
Medical Monitor and the Investigator. A D-dimer may be considered under circumstances in which FVIII activity levels ar
ears 3-
 
of the initial visit that had a positive result.
d AAV5 TAb
sits during Years 3-5.
e
f Sample testing during Long-Term Follow-
-Infusion Follow-
have not had 3 
Years 3-
 consecutive samples below the limit of detection are documente

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g
op 
assays used for these evaluations.  
associated with hemophilia A. While exploratory samples will be coll
performed only as deemed necessary by the Sponsor. 
h PRO assessments during Years 2-5 of Long-Term Follow-up should be performed at the 
. 
i
the Investigator.
j Subjects who meet the definition of treatment f
-
-5 may receive a scheduled monthly follow-up tel
ve not yet cleared vector shedding in one or more 
matrices must still provid
 
 3-
provide samples or by providing those samples to a MN professional.
 An optional liver biopsy may be performed at any time between Years 2-
-state, over 
 triggered is observed, the optional biopsy may be performed at the end of Year 5. Subjects should fast for at 
 hours prior to liver ultrasound and optional liver biopsies. More than one liver biopsy may be performed during this period, as clinically indicated. 
 
 
 

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Table 9.1.6:  Schedule of Events – Therapeutic Corticosteroids for ALT Elevations
Steroid Treatment Periodb
Post-Steroid Periodc
 
Week 1 
Week 2 
Week 3 
Week 4 
Week 5 
Week 6 
Week 7 
Week 8b 
Week 1 
Week 2 
Week 3 
Week 4 
Week 13
Therapeutic 
corticosteroids 
a  
 
 
 
 
 
30 mg 
20 mg 
 
 
 
 
 
 
FVIII activity 
testing  
 
 
 
 
 
 
 
 
 
 
 
 
 
Liver tests
 
 
 
 
 
 
 
 
 
 
 
 
 
Hepatitis B testingd
 
 
 
 
 
 
 
 
 
 
 
 
 
HCV Viral Loadd
 
 
 
 
 
 
 
 
 
 
 
 
 
a Therapeutic oral 
b Following initiation or completion of steroid regimen, if a recurrence of ALT values 
baseline value is reported, steroid management decisions will based on discussions 
onfounders 
for the ALT elevation, and adverse events related to steroid dosing. Guidance for tapering oral corticosteroid dosing can be found in Section
. 
c After discontinuation of oral 
If these assessments are already 
being done as part of normal study follow-up, they do not need to be duplicated. 
d Should only be performed in subjects with a history of hepatitis B or hepatitis C prior to study entry.
 
 
 
 

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Table 9.1.7:  Schedule of Events – Optional Liver Biopsy 
Within 28 Days Before 
Biopsy Day 
Within 7 Days Before 
Biopsy Day 
Biopsy Day (BD) 
Informed Consent for Liver Biopsy Procedure
a 
 
 
 
Physical examination 
 
 
 
Hematology, Coagulation, Chemistry Assessmentsb 
 
 
 
Liver Testsb
FibroScan 
 
 
 
 
 
 
*
*
Pre-Biopsy Consultationc 
 
 
 
Liver Biopsyd 
 
 
 
PBMC 
e
If Day -
-site study visit, they do not need to be duplicated here. 
* If the Day -7 and biopsy day visits occur on the same day, these tests do not need to be duplicated.
a 
ior to liver ultrasound.
b Refer to Table
for laboratory assessments to be included, and to Table
. for liver tests. 
c Subjects will undergo a pre-
d
ours prior to optional liver biopsy. Biopsy will be a percutaneous or transjugular biopsy under ultrasound guidance, performed according to the standard 
2 cm sample should still be retained and handled according to the instructions for handling biopsy specimens in the Laboratory Manual. Following completion of the biopsy, the subject 
-
-procedure observation may be done at the investigator’s discretion. 
e
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9.2 
Discussion of Study Design, Including Choice of Control Group 
Study 270-
-arm, open-label study in hemophilia A 
FVIII. Hemophilia A patients who provide written informed consent, meet the entry criteria 
definition of residual FVIII activity, have well-documented historical data for the previous 
 months concerning exogenous FVIII usage and bleeding episodes, and do not have 
antibodies to AAV5 will be eligible to enroll in the study. 
 270 dose. Subjects will 
initially be followed for 52 
-BMN 270 infusion, during which safety and efficacy 
-year analysis for the study will be performed after all 
-BMN 270 infusion. A separate 2-year analysis 
-
-year and 2-year analyses, safety and efficacy 
will then continue to be assessed long-term in all subjects for a total of approximately 
5 years.  During enrollment, the DMC will review available safety and efficacy data on an 
ongoing basis and may decide to recommend dosing 
-
assessment. 
Study 270-
-controlled study. Parameters for each subject will be compared to a 
pre-treatment assessme
 
9.3 
Selection of Study Population 
enroll into the study.  
Additional criteria for participation in the study are provided in Section 
 and 
Section 
. 
9.3.1 Inclusion Criteria 
Individuals eligible to participate in this study must meet all of the following inclusion 
criteria: 
 
 
 
evidenced by medical history, at the time of signing the informed consent.  
2. 
 months 
prior to study entry.  High-
-documented historical data concerning 
 months must be available.

 
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3. 
 
 Willing and able to provide written, signed informed consent after the nature of the 
study has been explained and prior to any study-related procedures. 
5. No previous documented history of a detectable FVIII inhibitor, and results from a 
Bethesda assay or Bethesda assay with Nijmegen modification of less than 
 consecutive occasions at least 
 
 
 Sexually active participants must agree to use an acceptable method of effective 
contraception, either double-
hormonal contraceptives or having an intrauterine device. Participants must agree to 
-
 
stop contraception use only if they have had 3 consecutive semen samples with viral 
vector DNA below the limit of detection. 
7. Willing to abstain from alcohol consumption for at least the first 52 
BMN 270 infusion. 
9.3.2 Exclusion Criteria 
Individuals who meet any of the following exclusion criteria will not be eligible to participate 
in the study: 
 Detectable pre-existing antibodies to the AAV5 capsid. 
2. Any evidence of active infection or any immunosuppressive disorder, including HIV 
infection.  
3. Significant liver dysfunction with any of the following abnormal laboratory results: 
 
 
 
 
 
-
 
 
 
 
 
 
 
Subjects whose liver laboratory assessments fall outside of these ranges may undergo 
repeat testing of the entire liver test panel within the same Screening window and, if 
eligibility criteria are met on retest, may be enrolled after confirmation by the 
Medical Monitor.   

 
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-
the Batts-
 
5. Evidence of any bleeding disorder not related to hemophilia A. 
 
 
7. 
 
 Liver cirrhosis of any etiology as assessed by liver ultrasound.  
 
Laboratory Manual. 
 Active Hepatitis C as evidenced by detectable HCV RNA or currently on antiviral 
therapy.  
Active malignancy, except non-
 
 History of hepatic malignancy. 
 
non-
-associated thrombosis for which 
anti-thrombotic treatment is not currently ongoing.  
 
illation. 
 Treatment with any investigational product within 30 days or 5 half-lives of the 
investigational product prior to the screening period. For subjects who have received 
hile 
receiving that investigational product must have resolved prior to screening for this 
study. 
Any condition that, in the opinion of the Investigator or Sponsor would prevent the 
 possible 
with evaluation and interpretation of subject safety or efficacy result. 
Prior treatment with any vector or gene transfer agent. 
Major surgery planned in the 52-w
 270. 
vaccines within 30 days before the BMN 270 infusion. 

 
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20. Concurrent enrollment in another clinical study, unless it is an observational 
-
the current protocol or have the potential to impact the evaluation of efficacy and 
safety of BMN 270 and with prior consultation with the Medical Monitor. 
rgy or hypersensitivity to BMN 270 investigational product formulation. 
22. 
9.3.2.1
Optional Liver Biopsy Inclusion and Exclusion Criteria
Individuals eligible for the optional liver biopsy must meet the following inclusion criterion: 
 
biopsy 
2. 
may be treated with additional exogenous FVIII replacement products in order to 
increase their FVIII levels activity to an appropriate level, under the 
Individuals who meet any of the following exclusion criteria will not be eligible for the 
optional liver biopsy: 
 Any condition that, in the opinion 
abnormalities detected on liver ultrasound performed 
ys that would preclude safe performance of 
the biopsy. 
9.3.3 Removal of Subjects from Treatment or Assessment 
Subjects may withdraw their consent to participate in the study at any time without prejudice. 
The Investigator must withdraw from the study any subject 
discuss with the subject appropriate procedures for withdrawal from the study.  
The 
 perform the procedures listed under the 
early termination visit.  Should a subject withdraw from the study, all efforts will be made to 
complete and report the observations as thoroughly as possible up to the date of the 
withdrawal.   
A subject’s participation in the study may be discontinued at any time at the discretion of 

 
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possible, the tests and evaluations listed for the termination visit should be carried out and 
every effort will be made to gather follow-up safety data if possible. 
BioMarin must be notified of all subject withdrawals as soon as possible. BioMarin also 
reserves the right to discontinue the study at any time for either clinical or administrative 
reasons and to discontinue participation by an individual Investigator or site for poor 
enrollment or noncompliance. 
Reasons for which the Investigator or BioMarin may withdraw a subject from the study 
include, but are not limited to, the following: 
 
 
 
 Subject was erroneously enrolled into the study or does not meet entry criteria and not 
yet been dosed with 
erroneously receive BMN 270 should remain in the study for safety monitoring 
 Subject is lost to follow-up 
If a subject fails to return for scheduled visits, a documented effort must be made to 
determine the reason. If the subject cannot be reached by telephone, a certified letter should 
recorded in the study records.  
Subjects may be considered lost to follow-up if the subject has missed 3 consecutive visits in 
the study and has failed to communicate a reason for this to the site. In addition, the site has 
without success in the following manner: 
 
 
 
letter or by appropriate local process. 
Where communication has been made by phone, this should be documented in the subject 
source notes. 
The Investigator or designee must explain to each subject, before enrollment into the study, 
that for evaluation of study results, the subject’s protected health information obtained during 
the study may be shared w
health information per country-specific regulations, such as the Health Insurance Portability 

 
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health information is withdrawn, it is the Investigator’s responsibility to obtain a written 
ject and the subject will 
be removed from the study. 
9.3.3.1
Study Safety Evaluation Criteria 
If any of the following events occur in a subject in the study who has received BMN 270 
into the 
trial will be temporarily put on hold if recommended by the DMC per Section 
.  
 
-hepatic 
 
o 
 
o 
and
or 
o 
2. 
 
3. The occurrence of an AE of hepatic failure. 
 The detection of high-
ing 
BMN 270 infusion in two subjects. 
5. 
-
BMN 270 infusion. 
 
 
subject. 
If any of the following events occurs in a subject in the study who has received BMN 270 
will continue while DMC evaluation is ongoing, unless deemed otherwise by the DMC: 
 The detection of high-
 
BMN 270 infusion in one subject. 
2. Occurrence of a thromboembolic event in one subject. 
9.3.4 Subject Identification and Replacement of Subjects
eCRF pages. In legal jurisdictions where use of initials is not permitted, a substitute identifier 
will be used. 
Subjects who withdraw from the study after receiving BMN 270 will not be replaced. 

 
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9.3.5 Duration of Subject Participation
 
 
-Infusion Follow-
-Term Follow-
 
9.4 
Treatments 
9.4.1 Treatments Administered 
completion of the study.  BioMarin is responsible for shipping study drug to clinical sites. 
9.4.2 Identity of Investigational Product 
9.4.2.1 
Product Characteristics and Labeling 
BMN 270 is a sterile, clear, colorless-to-pale yellow solution for IV infusion and is supplied 
®
 
 
of AAV5-hFVIII-SQ at a concentration of 2E
 phosphate buffer. 
The study drug is labelled according to the particulars approved by the relevant regulatory 
agencies.  
9.4.3 Storage 
At the study site, all IP must be stored under the conditions specified in the Pharmacy 
Manual in a secure area accessible only to the designated pharmacists and clinical site 
personnel. All IP must be stored and inventoried and the inventories must be carefully and 
accurately documented according to applicable state, federal and local regulations, ICH GCP, 
and study procedures. 
9.4.4 Directions for Administration
On the day of infusion, the subject will come to the infusion site, where a physical 
examination will be performed by the Investigator or designee. If the subject is found to have 
an active acute illness at the time of planned infusion, then the infusion should be deferred 
specified window.  An IV catheter or butterfly needle will be inserted into a suitable 
 
therapy will not be given since venipuncture is a minimally invasive procedure in these 
individuals under ordinary conditions. 

 
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BMN 270 will be prepared and infused as a pure solution over a dose-dependent time. 
pump will be used to infuse through an in-line, low protein binding 0.22 micron filter. 
BMN 270 will be infused through the catheter using an appropriate infusion pump at an 
 
 
increase. Of note, the IP has been shown to be stable at room temperature for 7.5 hours 
 
time 
period of the infusion.  
 270. Dosing will be 
medication available and easily accessible. 
Clinical staff administering BMN 270 should be trained appropriately in recognizing and 
managing the signs and symptoms associated with potential hypersensitivity, anaphylactic, 
and anaphylactoid reactions. Additionally, the Investigator should be familiar with 
Should symptoms of potential hypersensitivity occur, the infusion may be slowed or halted at 
the Investigator’s discretion, with consideration of the subject’s clinical condition. If the 
infusion is halted, it should only be restarted if the Investigator considers it safe and 
appropriate to do so. Antihistamines, anti-
icosteroid administration is 
permitted prior to restarting an interrupted infusion by an infusion-related reaction. At the 
 
 
 
 
In case of hypersensitivity or adverse drug reaction, safety assessment, including physical 
examination and vital signs, will be done and additional blood samples will be collected 
and cy
-
 hours 
-patient observation 
can be extended and additional blood samples can be collected if deemed necessary at the 
discretion of the Investigator and Medical Monitor. 

 
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Following completion of the infusion, vital signs will be 
If the vital
Hemostasis at the puncture site will be established by applying pressure according to 
standard protocol for infusing FVIII concentrates. Subjects will remain in the clinic for at 
l
 hours to observe for any immediate toxicity of the 
-patient observation 
transfer to a separate facility based on the evaluation and judgment of the Principal 
Investigator after consultation with the Medical Monitor. 
Prior to discharging subjects from the clinic, the Investigator or designee should instruct 
reactions 
case of such an event. 
9.4.5 Method of Assigning Subjects to Treatment Groups 
 
 and Section 
prior to enrollment 
 
 
 
9.4.6 Selection of Dose Used in the Study 
Data from an ongoing first in 
-
-related increases 
in FVIII activity were observed, with concurrent improvements in bleeding episodes and 
exogenous FVIII u
levels, BMN 270 is considered to be well-tolerated with mild increases in ALT as the most 
common adverse event. Please refer to the IB for detailed efficacy and safety data.  
In order to further evaluate the dose-response relationship of BMN 270, subjects will be 
clinical experience to date in 270-
efficacy 
 
 
9.4.7 Blinding 
This is an open-label study. 

 
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In order to minimize bias and to preserve the scientific and business integrity of the 
single-arm and open-
This document provides guidelines for accessing post-treatment study data and applies to 
study team members, including personnel from within BioMarin, from external vendors and 
service providers, from the DMC, and from study sites. Role-based access control to study 
data, both individual patient-level data values as well as aggregated summaries of 
longitudinal data in an individual patient or across multiple patients, has been implemented to 
minimize potential bias and achieve appropriately controlled decision-
preserving operational efficiency. It is enforced by the DAP that individuals who are 
ey efficacy results.
9.4.8 Prior and Concomitant Medications 
All prescription and over-the-
 days before Screening will be recorded on the designated eCRF. 
The Investigator may prescribe additional medications, deemed necessary to provide 
medication is not prohibited by the protocol. In the event of an emergency, any needed 
medications may be prescribed without prior approval, but the Medical Monitor must be 
notified of the use of any contraindicated medications immediately thereafter. Any 
concomitant medications added or discontinued during the study should be recorded on the 
eCRF. Medications should, whenever possible, not be recorded in the electronic database 
 
The following medications are prohibited starting 30 days before Screening and through the 
end of the study, and the Sponsor must be notified if a subject receives any of these during 
the study: 
 Any investigational therapy other than BMN 270 
 Emicizumab 
 Fitusiran 
 Concizumab 
 Efavirenz 

 
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The following medications should be avoided, starting 30 days prior to and for at least 
52 
zed throughout the remaining duration of the 
study. 
 Alcohol  
Herbal and natural remedies and dietary supplements
Medications which may be hepatotoxic, including isotretinoin and 
Medications which may reduce or increase the plasma concentration of 
corticosteroids 
Subjects should be counseled to avoid starting potentially hepatotoxic therapies and to inform 
the Investigator of any new medications prescribed by other physicians. Investigators should 
carefully consider both the mechanism of action and potential hepatotoxicity of any new 
medication prior to initiation. If a potentially concerning new medication is started, 
 
safety of BMN 270 have occurred. If co-
Liv
NCBI 2020  
unless clinically indicated. 
Administration of SARS-CoV-2 vaccine after BMN 270 infusion may occur after 
consultation between Investigator and Medical Monitor. Investigators should use clinical 
related to timing of vaccine administration. 
The following medications should be avoided during oral corticosteroid therapy: 
 Vaccines 
 NSAIDs 
9.4.8.1 
Concomitant Hemophilia Treatments 
Subjects on prophylactic FVIII therapy will discontinue their regular treatment regimen 
 and bleeding episodes in his 

 
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diary. Prophylactic FVIII use can be used on a case-by-case basis and in consultation with 
-
 
In addition, information on FVIII usage and bleeding episodes by medical history must be 
well-
-month period 
immediately preceding study enrollment.  Further information on the details that should be 
provided as part of the subject’s well-documented medical and FVIII usage history are 
provided in the On Site File Binder. 
In order to enable rigorous comparisons of pre-study versus on-study FVIII usage and 
bleeding episodes, the Medical Monitor will review each screened patient’s prior bleed and 
hemophilia medication logs to determine if they are of "high-
following: 
 
ation of bleeds 
 
one-
 
9.4.8.2 
Reactive Glucocorticoid Treatment and/or Immunosuppressive Agent 
Treatment of Elevated Hepatic Transaminases 
Refer to corticosteroid prescription guidelines for recommended monitoring for, and 
management of, potential side effects of corticosteroids, including guidance on medications 
that should be avoided during corticosteroid treatment.  
either of the following occurs post-BMN 270 infusion in any subject and after consultation 
 
 
baseline value in 2 consecutive assessments within 72 hours 
 consecutive 
 Table 
 
o
Whenever possible, a confirmatory lab draw for ALT should be 
performed, along with FVIII activity, prior to initiating reactive oral 
corticosteroids. 
o
Corticosteroids may be delayed if elevations in ALT are clearly not related 
Monitor 
BMN 270 
.  

 
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o Alternative immunosuppressive agents may also be considered for use on 
a case-by-case basis and following consultation with the Medical Monitor 
 
steroid treatment should be initiated at a dose of 
Should a scenario arise in which differences from the minimum 
reactive corticosteroids may be clinically indicated, a 
corticosteroid dose adjustments. Management of ALT elevations with reactive 
elevations, should be guided by the following Table

 
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Table 9.4.8.2.1:  Management of ALT Elevations with Reactive Corticosteroids 
 
 
Repeat LTs and FVIII 
-72 hours 
Continue to monitor LTs until ALT is stable or not increasing
 
autoimmune hepatitis, alcohol use, recreational drug use, special diets, strenuous 
exercise, prio
 
If no alternative etiology is found, initiate reactive corticosteroids with the 
Monitor
 
 
 
Consider obtaining other possibly relevant laboratory evalua
 
 
Consider obtaining complete blood count with differential to assess for 
eosinophilia 
 
Consider obtaining PBMC, C3, C3a, Bb, and sC5b-
oral 
 
 
Continue to taper as long as subject’s ALT is not increasing. Decisions 
regarding regimen modification may be made based upon Investigator 
judgement and discussion with the Medical Monitor 
 
consult the 
Medical Monitor prior to initiating corticosteroids unless there is an imminent 
safety concern 
Worsening ALT 
following is recommended: 
 
Investigate for alternative etiologies including labs noted above, if not 
 
 
 
For subjects who are refractory to the maximum dose of corticosteroids, or 
intolerant to use of corticosteroids, consider use of alternative 
 
 
 
Any concerns should be discussed between the Investigator and the Medical Monitor 
Recurrent ALT 
elevations 
safety concerns, the decision regarding management may be made at the discretion of the 
Investigator after discussion with the Medical Monitor 
Medical Monitor regarding corticosteroid dose adjustments.
 

 
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When ruling out alternative viral or autoimmune hepatitis as part of the elevated ALT 
Table 
 
Table 9.4.8.2.2:  Viral and Autoimmune Hepatitis Testing
Viral Hepatitis Workup Testing
Autoimmune Hepatitis Workup Testing
Hepatitis A
Smooth muscle antibody
Hepatitis B 
Mitochondrial antibody 
Hepatitis C 
 
Hepatitis E
-2 
 
Epstein-
 
After discontinuation of reactive oral corticosteroids, labs for ALT and FVIII levels will be 
 
Following completion of reactive oral 
  
 
management decisions will be based on 
discussions between the Investigator and Medical Monitor. Modification of the corticosteroid 
on FVIII expression.  
Management and monitoring of reactions to corticosteroids should be determined by the 
Investigator’s clinical judgment in consultation with the Sponsor’s Medical Monitor. 
This includes the contraindicated use of NSAIDs during corticosteroid treatment and specific 
monit
-2 inhibitors, 
while not contraindicated during corticosteroid treatment, should be limited, if possible.  
Practical management to prevent complications related to oral corticosteroid therapy may be 
-steroidal systemic immunosuppressive agents may be 
used, following a discussion between the Investigator and the Medical Monitor, should 
corticosteroid use be deemed by an Investigator to be clinically ineffective, not tolerated, 
 
after the start of oral 
 
 
 
oral 
events suspected to be caused by 
should be reported as outlined in Section 
 of the protocol. 

 
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Subjects on corticosteroids should receive appropriate counselling and support regarding side 
including the co-prescription of additional medications to prevent complications related to 
but not limited to, prophylaxis against the occurrence of gastric ulcers, osteoporosis, and 
infections. The above guidance should also be followed in the event that an alternative 
immunosuppressive agent is used, as applicable. 
9.4.8.3
Monitoring of HIV-Positive Subjects 
HIV-positive subjects who have previously enrolled in 270-
anti-
.  No alterations in the monitoring are 
indicated for enrolled immunocompetent HIV-positive subjects who receive corticosteroids 
as part of their enrollment in 270-
. 
9.4.9 Treatment Compliance 
t be 
recorded on a dispensing log.  Sites will be instructed to return or destroy all used and unused 
study drug containers. 
9.5 
Investigational Product Accountability 
s 
The Investigator or designee must retain all unused or expired study supplies until the study 
-
 by local SOPs. 
9.5.1 Return and Disposition of Clinical Supplies
the study monitor. The Investigator or designee must provide an explanation for any 
destroyed or missin
only after BioMarin has granted approval for drug destruction. The monitor must account for 
all study drug in a formal reconciliation process prior to study drug destruction. All study 
drug destroyed on site must be documented. Documentation must be provided to BioMarin or 

 
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designee and retained in the Investigator study files. If a site is unable to destroy study drug 
study drug or study drug materials must be accounted for on a study drug return form 
provided by BioMarin. 
All study drug and related materials should be stored, inventoried, reconciled, and destroyed 
or returned according to applicable state and federal regulations and study procedures.  
For additional information, please refer to the Pharmacy Manual. 
9.6 
Dietary or Other Protocol Restrictions
There are no dietary or other protocol restrictions for this study. Alcohol should be avoided 
for the first 52
Alcohol use should be minimized throughout the remaining duration of the study. 
Subjects should be advised to abstain from any blood or sperm donation after BMN 270 
infusion, until there is no further evidence of vector shedding from PCR analysis of samples. 
Subjects should also abstain from organ donation. 
9.7
Safety and Efficacy Variables 
9.7.1
Safety and Efficacy Measurements Assessed
Table 
 through Table 
evaluations.
9.7.2 Primary Efficacy Variables
9.7.2.1 
FVIII Activity 
The primary efficacy variable is change of the hFVIII activity, as measured by chromogenic 
-52 post-BMN 270 infusion from baseline. Each subject’s 
-52 is defined as the median of the values obtained during 
-
 hours 
since the last infusion of exogenous FVIII protein concentrates.  
If a subject has used FVIII within 72 hours of a measurement day, all efforts should be made 
to obtain FVIII activity measurements when a 72-hour interval without FVIII use is 
-hour wash-out period is only intended for subjects who have achieved 
 5 
ho have not resumed FVIII 
replacement therapy. 

 
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monitoring of FVIII activity levels is not needed in the absence of a concurrent or recent 
ALT elevation or upon consultation between the Investigator and the Medical Monitor. 
independence from prophylactic FVIII replacement therapy due to joint bleeding episodes, in 
with the Medical Monitor or Sponsor-designated Data Monitor, follow an abbreviated visit 
schedule afte
 
during Years 2-5. 
-5 may 
receive a scheduled monthly follow-
events
  
Details on collecting FVIII activity samples are included in the Laboratory Manual.  
9.7.3 Secondary Efficacy Variables
9.7.3.1
Factor VIII Replacement Therapy/Bleeding Episodes 
Secondary efficacy variables are:
 
utilization of exogenous FVIII replacement therapy.  
 Change in the annu
the baseline ABR.   
 months in order to be 
report the use of factor replacement therapy and the number of bleeding episodes since the 
previous visit. This information will be captured on the subject’s diary or other subject 
records. Subjects will be encouraged to discuss any bleeding episodes with the Investigator 
and attempt to objectively assess any reported bleeds through use of ultrasound or non-
invasive imaging. 
Subjects are strongly encouraged to immediately consult Investigator for guidance regarding 
exogenous FVIII administration for suspected bleeds or bleeding episodes within the first 
30 days post BMN 270 infusion. 

 
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In subjects who experience recurrent bleeding episodes, the Investigator and Medical 
Monitor will discuss whether to resume prior FVIII prophylaxis. 
9.7.4 Tertiary Efficacy Variables
9.7.4.1 
Patient-Reported Outcome (PRO) Measures
The Haemo-QoL-
 a validated hemophilia-specific health-
 
Impact and Treatment 
-
-type scale, ranging 
-related 
Haemo-
Details regarding the Haemo-QoL-A assessment will be included in the On Site File Binder.
The EQ-5D-5L instrument is a self-
health status 
EQ-5D-5L is composed of 
2-
self-
 dimensions and the 
opy of the 
EQ-5D-5L and additional information are provided in the On Site File Binder. 
-perceived 
consists of multiple 
transportation, self-
rate their level of difficulty with activities of daily livi
-
-type scale from 
 
‘Not applicable’.  A sample copy of the HAL and additional information are provided in the 
On Site File Binder. 
y and Activity Impairment plus Classroom Impairment Questions: 
absenteeism, reduced on-the-
with higher numbers ind
Reilly 2002
A 
File Binder. 

 
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designed to investigate and directly probe patient perspectives on outcomes they deem 
relevant to their life and care. PROBE aims to develop a new global tool to enhance the 
direct patient-voice in health care decision-
Chai-
collected in 270-
ation are 
provided in the On Site File Binder. 
9.7.5 Immunogenicity 
Immunogenicity assays will be performed on plasma and PBMCs. The assays will include 
detection of anti-AAV5 capsid and anti-FVIII total antibodies, as well as determination of 
neutralizing antib
Nijmegen modification. Any abnormality of the liver parameters will lead to a retrospective 
immunogenicity assessment to evaluate FVIII- and capsid-specific cellular immunogenicity. 
FVIII- and capsid-
secretion using an ELISpot assay performed on collected PBMCs. 
9.7.6 Pharmacodynamics 
The FVIII protein concentration and activity level as measured by a validated immunoassay 
protein and activity will be used to determine PD parameters. 
9.7.7 Exploratory Assessments 
Blood samples will be collected from subjects at the time points indicated in Table 
, 
Table 
2, Table 
, Table 
, and Table 
 to evaluate biochemical, molecular, 
gene transfer, and to develop assays used for these evaluations.  Subjects may choose to opt 
mophilia A. 
In addition, samples collected for other purposes in this study may be used for exploratory 
research once testing for the primary purpose has been completed.   

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9.7.7.1
Optional Liver Biopsy
and collection of tissue in the study ICF. The analysis of the optional liver biopsy is 
considered exploratory. Subject who elect to proceed will have a liver biopsy performed 
-
 2-5. Additional liver 
-5. Su
procedure for each liver biopsy performed during the study. 
Subjects who consent to the procedure will have a liver biopsy via either transjugular or 
-
according to the standard procedures of the 
institution. Two tissue cores will be harvested in the context of the optional liver biopsy. 
-hour fasting period before the procedure. 
must have a documented FVIII 
within 7 days before the biopsy and again on the day the biopsy, prior to the procedure. As 
needed, subjects may be treated with additional exogenous FVIII replacement products in 
order to increase their FVIII activity levels to an appropriate level, under the 
tigator, to ensure the safety of the subject during the 
 
iopsy are outlined in Table 
. 
Subjects consenting to participate to the optional liver biopsy will undergo pre-biopsy 
before the procedure, as follows: 
Physical examination
Hematology, coagulation, chemistry assessments
Liver tests
FibroScan
Subjects consenting to participate to the optional liver biopsy will undergo pre-
biopsy assessments 
 7 days before the procedure, as follows: 
Local FVIII activity level assessment
Pre-

 
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On the day of the biopsy, brief physical examination and liver and blood tests should be 
activity assessment should also be performed to ensure the subject has sufficient FVIII 
activity to protect against procedure-
and a whole blood draw for PBMC collection should be performed on the biopsy day 
or 
The optional liver biopsy should be performed in the morning if feasible, and the biopsy 
procedure and follow-up care should be done according to the local standard of care. 
Additional details for handling the biopsy specimens are provided in the Laboratory Manual. 
Following completion of the biopsy, the subject should remain under observation in the clinic 
-
-procedure observation may be done at the investigator’s 
 
Clinically significant findings reported from the histopathological analysis of the biopsy 
samp
and followed as clinically appropriate to manage the subject’s medical care. A hepatologist 
 
9.7.8 Safety Variables 
Safety in this study will be determined from evaluation of AEs, clinical laboratory 
assessments with a particular attention to the liver function, vital signs assessments, physical 
examinations, and immunogenicity. 
9.7.8.1
Adverse Events 
The determination, evaluation and reporting of AEs will be performed as outlined in 
Section 
. 
9.7.8.2 
Clinical Laboratory Assessments 
The scheduled clinical laboratory tests are listed in Table 
. Refer to the On Site File 
Binder for instructions on obtaining and shipping samples. 
Any abnormal test results determined to be clinically significant by the Investigator should 
be repeated 
determines that the abnormal value is no longer clinically significant. 

 
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All abnormal clinical laboratory results should be initialed and dated by an Investigator, 
along with a comment regarding whether or not the result is clinically significant. 
Each clinically significant laboratory result should be recorded as an adverse event. 
The 
considered clinically significant by the Investigator will be recorded on the AE eCRF. 
Table 9.7.8.2.1:  Clinical Laboratory Tests 
Blood Chemistry 
Hematology
Urine Tests
Coagulation Screen 
including:
Albumin 
Hemoglobin 
Appearance 
APTT 
 
Hematocrit 
Color 
 
Calcium 
WBC count 
pH 
TT 
Chloride 
RBC count 
Specific gravity 
 
Total cholesterol 
Platelet count 
 
 
 
Differential cell count 
Protein 
 
Creatinine 
 
Glucose 
 
CRP 
 
Bilirubin 
 
Glucose 
 
Nitrite 
Other Tests 
Phosphorus 
 
 
ABO blood typing* 
Potassium 
 
Hemoglobin 
 
Total protein 
 
 
 
Sodium 
 
 
 
 
 
 
 
-
international 
 
*ABO blood typing assessment should be performed at Baseline, or at another regularly scheduled visit prior to the end of 
the subject’s participation in the study. 
In addition to scheduled clinical laboratory assessments, a fasting blood lipid panel 
 hours prior to 
pre-infusion laboratory sampling on the day of the infusion visit. 
In case of hypersensitivity or adverse drug reaction, safety assessment, including physical 
examination and vital signs, will be done and additional blood samples will be collected 

 
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At applicable sites, certain study assessments designed in the Schedule of Events may be 
location, such as their school or office, to improve access and convenience for patients 
participating in the study. The Sponsor may select a healthcare company that will be 
MN 
in good standing, as per applicable regulations, and that appropr
been performed. If the investigator at a participating site determines that MN services are 
appropriate for a patient and the patient gives written informed consent to participate in 
MN 
th the patient and the patient’s site.  
Years 3-
 2-5 will not be 
performed by an MN professional but will be done at the study site. For subjects who have 
enrolled in 270-
-
MN services may be used if the subject is unable to attend the site to complete the study visit 
during the acceptable window for that visit, upon prior approval by the Medical Monitor and 
discussion between the Medical Monitor and Investigator. 
In the event that neither a lab-only visit or MN visit can be conducted for a post-infusion 
visit, the site should telephone the subject to collect adverse event, concomitant medication, 
and welfare. 
9.7.8.3 
Malignancies 
Liver ultrasounds will be performed annually at each End of Year visit starting at Year 2 
be performed between the End of Year visits at the discretion of the Investigator. 
xcept non-
reporting. In addition, it is recommended that genomic analyses be performed on any 

 
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The study site will coordinate sending samples from the malignancy for genomic analyses, if 
available.
9.7.8.4
Liver and Hepatitis Testing
Subjects will be screened for evidence of previous or active hepatitis B or hepatitis C 
Subjects with documented results showing an absence of active hepatitis B or hepatitis C 
hepatitis 
tests during the screening period.  
Evidence of ongoing hepatitis B or hepatitis C infection is exclusionary. Subjects with a 
history of hepatitis B or hepatitis C infection prior to study entry will be tested for hepatitis B 
history of hepatitis B or hepatitis C 
assessment at Screening. 
Subjects with a previous history of hepatitis B or hepatitis C who receive therapeutic oral 
corticos
points listed in Table 
. 
dysfunction.  
assessed: 
Table 9.7.8.4.1:  Liver Tests 
Liver Tests (LTs)
 
 
Total Bilirubin 
LDH
 
Direct Bilirubin 
GGT
-
-
-pyruvic transaminase
d according 
to the plan outlined in Table 
 
testing of LTs and FVIII levels at unscheduled 

 
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be completed by a mobile nursing professional at sites where the use of MN services has 
 
9.7.8.5
HIV Testing
HIV testing will be performed at Screening.  Subjects with documented negative results 
within the last 30 days prior to screening do not need to be retested. 
9.7.8.6
Vital Signs, Physical Examinations and Other Observations Related to Safety 
Vital signs will include seated systolic and diastolic blood pressure, heart rate, respiration 
rate, and temperature. Any clinically significant change in vital signs will be recorded as an 
AE. 
Systolic blood pressure, diastolic blood pressure, heart rate, respiration rate, and temperature 
will be assessed at Screening, Baseline, and at the beginning of each visit during the 
Post-Infusion Follow-
-Term Follow-
 270 
 minutes 
 hours during the 
subject’s stay in the clinic.  Any abnormal vital sign assessments should be repeated, and 
both values should be recorded in the eCRF. 
 
52 and 
performed at the discretion of the Investigator based on the subject’s clinical condition. 
Particular attention should be given to signs of bleeding, as well as assessing possible 
draw-only visits are conducted at the sites, the physical examination and vital signs 
assessments indicated in the Schedule of Events will not be performed. 
A complete physical examination will 
. The genitourinary examination may be deferred for 
-related complaints. 
A brief physical examination will include general appearance, cardiovascular, dermatologic, 
ts. 
Height will be recorded at Screening only. Weight will be recorded at Screening and then 
every End of Year visit during Years 2-5. 

 
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9.7.8.7
Vector Shedding 
During the Post-Infusion Follow-
 
 Blood 
 Saliva
Semen
Stool 
Vector shedding will also be extensively studied in the present clinical trial, at the time points 
indicated in Table
, Table
, Table
, Table
, and Table
. Testing will 
continue until at least 3 consecutive results below the limit of detection are obtained. If a 
positive result is obtained in a matrix after 3 consecutive results below the limit of detection 
have already been recorded, testing in that matrix should restart and continue until an 
additional 3 consecutive results below the limit of detection have been obtained in order to 
confirm clearance. 
 
below 
the limit of detection have been recorded in that compartment prior to that time point.  
Subjects who have not had 3 consecutive semen samples below the limit of detection by 
 
 
-
 consecutive samples below the limit of detection
Subjects who meet the definition of treatment failure and wish to follow an abbreviated 
sc
 
Year
 
Years 3-
designated study visit dates either at the sites or through use of a MN professional.  
Samples may be fractionated prior to shedding analysis in order to better characterize the 
If needed, the fractionation may be performed with samples collected specifically for 
characterization during shedding analysis may utilize already fractionated exploratory 

 
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samples obtained from the above biofluids, such as exploratory plasma samples, exploratory 
PBMC samples, and red blood c
 
Fractionation of semen to collect purified sperm separately from non-sperm cells may be 
performed in parallel at any visit where semen samples are collected.  The shedding analysis 
of a fractionated semen sample will only be performed if vector DNA was detected in the 
whole semen sample for the same visit.  Fractionation of semen during shedding analysis 
may be stopped if purified sperm tested positive for vector DNA on at least three visits, or if 
purified sperm tested negative for vector DNA on at least three consecutive visits.
only if they have had 3 consecutive semen samples with viral vector DNA below the limit of 
 
Details for sample collection and storage are provided in the Laboratory Manual. 

 
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10 
REPORTING ADVERSE EVENTS
10.1 
Safety Parameters and Definitions 
Safety assessments will consist of monitoring and recording protocol-
measurement of protocol-
measurement of protocol-spec
-defined events of special 
interest that are deemed critical to the safety evaluation of the study drug.
10.1.1 Adverse Events 
temporally associated with the use of study intervention, whether or not considered related to 
the study intervention.  
emporally associated with the 
use of study intervention.  
Events meeting the AE definition include: 
 Exacerbation of a chronic or intermittent pre-existing condition including either an 
 
 New conditions detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study. 
 
-drug interaction. 
Events not meeting the AE definition include: 
 Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the subject’s condition. 
 
condition. 
 
leads to the procedure is the AE. 
 
 Anticipated day-to-day fluctuations of pre-
present 
or detected at the start of the study that do not worsen. 

 
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10.1.1.1
Bleeding and Suspected Bleeding Events 
All bleeding events and suspected bleeding events, regardless of the need for exogenous 
FVIII therapy as treatment, should be captured in subject diaries and recorded on the 
designated bleeding eCRF.  Bleeding events and suspected bleeding events should not be 
reported as adverse events, with the following exception: 
 All bleeding events and suspected bleeding events which meet one or more of the 
criteria 
 
hemoph
 
10.2 
Serious Adverse Events
 
 Results in death 
 Is life-threatening  
Note: Life-threatening refers to an event in which the subject was at risk of death at 
the time of the event. It does not refer to an event, which hypothetically might have 
caused death, if it were more severe. 
 
 
Note: I
office or outpatient setting. If the investigational product preparation, infusion, and 
post-
completion, in the absence of an AE, this will not be considered an SAE. 
Complications that occur during hospitalization are AEs. If a complication prolongs 
hospitalization, the event is serious. 
Hospitalization for elective treatment of a pre-existing condition that did not worsen 
from baseline is not considered an AE.  
 Results in persistent or significant disability or incapacity 
 Is a congenital anomaly or birth defect in the child or fetus of a subject exposed to IP 
prior to conception or during pregnancy 
 Is an important medical event or reaction – that, based on medical judgment, may 
jeopardize the subjec
  

 
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10.2.1 Events of Special Interest (EOSI)  
 hours of site awareness, 
irrespective of seriousness, severity or causality:  
 
baseline value, regardless of whether that 
elevation triggers an initiation or modification of oral corticosteroid treatment 
 
 
 Thromboembolic event 
 Development of anti-
 
Any new diagnosis of 
-
10.3 
Methods and Timing for Capturing and Assessing Safety Parameters
10.3.1 Adverse Event Reporting Period 
The study AE reporting period is as follows:
 After informed consent but prior to initiation of study drug, only SAEs associated 
with any protocol-imposed interventions will be collected.  AEs occurring during this 
time period should be recorded on the Medical History eCRF. 
 After informed consent is obtained and following infusion of study drug, the 
reporting period for all non-serious AEs and SAEs begins and continues for 
approximately 5 
 
The criteria for determining, and the reporting of SAEs is provided in Section 0.2.  
10.3.2 Eliciting Adverse Events 
-ended and 
non-
 
10.3.3 Assessment of Seriousness, Severity, and Causality 
The Investigator responsible for the care 
 
 for 
SAE definitions

 
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10.3.3.1
Seriousness 
based on the 
seriousness criteria enumerated in Section 
.  Seriousness serves as a guide for defining 
regulatory reporting obligations. 
10.3.3.2
Severity
 
threat to a subject’s life or functioning. The Investigator will determine the severity of each 
corresponding CTCAE term will be assessed according to the general guidelines for grading 
Table 
. 
Table 10.3.3.2.1:  Adverse Event Grading (Severity) Scale 
Grade
Description
 
Mild: 
indicated
2 
Moderate: 
-appropriate 
a
3 
Severe or medically significant but not immediately life-threatening: hospitalization or 
-care ADLb 
 
 
should always be 
reported as SAEs 
5 
Death related to AE 
a Instrumental ADL refer to the following examples: preparing meals, shopping for groceries or clothes, using the telephone, 
managing money. 
b Self-care ADL refer to the following examples: bathing, dressing and undressing, feeding oneself, using the toilet
medications, not bedridden. 
10.3.3.3
Causality 
documents and AE eCRF.  To ensure consistency of causality assessments, Investigators 
should apply the guidance in Table 
. 

 
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Table 10.3.3.3.1:  Causality Attribution Guidance 
Relationship
Description
Not Related 
 
agents has not occurred 
OR 
 
immunosuppressant agents and the occurrence of the AE are not reasonably 
related in time  
OR
 
the IP 
there are no facts, evidence, or arguments to suggest a causal relationship to 
 
 
Related 
 
The administration of the I
immunosuppressant agents and the occurrence of the AE are reasonably 
related in time 
AND 
 
The AE could not possibly be explained by factors or causes other than 
unosuppressant 
agents 
OR 
 
immunosuppressant agents and the occurrence of the AE are reasonably 
related in time  
AND 
 
corticosteroids 
 
 
 Plausible temporal relationship 
 Absence of alternative explanations 
 Rarity of event in a given patient or disease state 
 
immunosuppressant agent exposure 

 
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 Consistency with study product pharmacology 
orticosteroid 
Similarity to adverse reactions seen with related drug products 
AE with reintroduction of 
The Investigator’s assessment of causality for individual AE reports is part of the study 
documentation process.  Regardless of the Investigator’s assessment of causality for 
individual AE reports, the Sponsor will promptly evaluate all reported SAEs against 
cumulative product experience to identify and expeditiously communicate possible new 
safety findings to Investigators and applicable regulatory authorities. 
10.4 
Procedures for Recording Adverse Events
10.4.1 Recording Adverse Events on an eCRF
Investigators should use precise medical terminology when recording AEs or SAEs on the 
 
Record only one diagnosis, sign, or sympt
In order to classify AEs and diseases, preferred terms will be assigned by the Sponsor to the 
original terms entered on the AE 
10.4.1.1 
Diagnosis versus Signs and Symptoms
The Investigator will attempt to establish a diagnosis of the event based on signs, symptoms, 
erminology, 
appropriate. 
10.4.1.2 
Adverse Events Occurring Secondary to Other Events 
dehydration, it is sufficient to record only diarrhea as an AE or SAE on the AE eCRF.  

 
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recorded as independent events on the AE eCRF.  For example, if severe hemorrhage leads to 
renal failure, both events should be recorded separately on the AE eCRF. 
10.4.1.3
Persistent or Recurrent Adverse Events
without resolution, between subject evaluation time points.  Events that change in severity 
necessitate the recording of an additional AE.  AEs that do not have a change in severity 
should be recorded only once on the eCRF. 
A recurrent AE is one that occurs and resolves between subject evaluation time points, but 
but the subject’s ALT increases again, that should be reported as two adverse events – the 
initial ALT increase, and the second ALT increase.   
10.4.1.4
Abnormal Laboratory Values 
Laboratory test results will be recorded on the laboratory results pages of the eCRF, or 
appear on electronically produced laboratory reports submitted directly from the central 
laboratory, if applicable. 
Any laboratory result abnormality fulfilling the criteria for a SAE or EOSI should be reported 
as such, and recorded in the AE eCRF. 
 an SAE in 
the AE eCRF. 
A clinical laboratory abnormality is considered clinically significant and should be 
documented as an AE if not refuted by a repeat test to confirm the abnormality and any one 
or more of the following conditions is met: 
 Accompanied by clinical symptoms 
 
discontinuation of, or any other change in a concomitant medication, therapy or 
 
 
 
 The abnor
-up assessments, further 
 

 
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This applies to any protocol and non-protocol specified safety and efficacy laboratory result 
from tests performed after the first dose of study medication that falls outside the laboratory 
reference range and meets the clinical significance criteria. 
This does not apply to any abnormal laboratory result that falls outside the laboratory 
explicitly exempted by the protocol, or those which are a result of an AE that has already 
been reported.
For purposes of this study, laboratory tests showing a decreased level of FVIII activity 
should not be reported as adverse events unless there is an impact to clinical outcomes 
 increased rate of bleeding, w
 
10.4.1.5
Pre-existing Conditions 
A pre-existing condition is one that is present prior to administration of BMN 270.  
Such conditions should be recorded as medical history on the appropriate eCRF. 
A pre-existing condition should be recorded as an AE or SAE during the study only if the 
important to convey the concept that a pre-existing condition has changed by including 
applicable language in the v
more frequent 
 
10.4.1.6 
General Physical Examination Findings 
At screening, any clinically significant abnormality should be recorded as a pre-existing 
 
documented as an AE or SAE on the AE eCRF. 
10.4.1.7 
Hospitalization, Prolonged Hospitalization, or Surgery 
Any AE that results in hospitalization or prolonged hospitalization should be documented 
and reported as an SAE unless specifically instructed otherwise in th
Section 
 
is no occurrence of an AE.  These scenarios include planned hospitalizations or prolonged 
hospitalizations to: 
 Perform a protocol-mandated efficacy measurement 

 
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-existing medical 
condition that has not worsened 
Insert an in-
-a-
for administration of study drug or FVIII replacement therapy 
10.4.1.8 
Deaths 
All deaths that occur during the 
 
attribution, will be recorded on the AE eCRF and expeditiously reported to the Sponsor as an 
SAE. 
When recording a death, the event or condition that caused or contributed to the fatal 
outcome should be recorded as the single medical concept on the eCRF.  If the cause of death 
 
10.4.1.9 
Pregnancy 
should be reported expeditiously to the Sponsor to facilitate outcome monitoring by the 
Sponsor.  Pregnancy in partner should be reported during the period up to 5 years after viral 
infusion. 
pregnancy by entering the information on the Pregnancy eCRF and submitting to BPV within 
 
on on the Pregnancy Follow-up eCRF. 
In 
every reasonable attempt to obtain the woman’s consent for release of protected health 
information. 
Abortion, whether therapeutic 
expeditiously reported to the Sponsor as an SAE. 
10.5 
Reporting Requirements 
10.5.1 Expedited Reporting Requirements 
All SA
Section 
 be reported by entering 

 
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 hours of the site becoming 
aware of the event.  Investigators should not wait to collect information that fully documents 
the event before notifying BPV of an SAE.  Bio
soon as it becomes available.  IND safety reports will be submitted within 7 calendar days for 
fatal or life-
 and within 
 calendar days for other non-life-threatening
The Sponsor is responsible for identifying, preparing 
relevant competent authorities, ethics committees and Investigators in accordance with the 
 
If the EDC is unavailable, all SAEs should be reported to BPV by completing the SAE 
 hours of the site 
becoming aware of the event.  Once the EDC is available, the information should be entered 
in the AE eCRF.
10.5.2 Institutional Review Board or Independent Ethics Committee Reporting 
Requirements 
 
10.6 
Follow-up of Subjects after Adverse Events 
proactively follow each 
stabilization, the event is otherwise explained, or the subject is lost to follow-up. Resolution 
umented on the AE eCRF and submitted to 
BioMarin Pharmacovigilance and in the subject’s medical record to facilitate source data 
verification.
For some SAEs and EOSI, the Sponsor may follow up by telephone, fax, electronic mail, 
EOSI report.

 
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10.7 
Post-Study Adverse Events 
At the last scheduled visit, the Investigator should instruct each subject to report, to the 
 
The Investigator should notify the study Sponsor of any death or SAE occurring at any time 
after a subject has discontinued or terminated study participation, if the Investigator believes 
that the death or SAE may have been related to prior study drug. The Sponsor should also be 
notified if the Investigator should become aware of the development of cancer or of a 
this study.  
10.8 
Urgent Safety Measures 
t
that may affect the safety of subjects, and that the appropriate regulatory bodies should be 
notified according to their respective regulations. According to the Eu
occurrence of any new event relating to the conduct of the trial or the development of the 
ely to affect the safety of the 
protect the patients against any immediate hazard. The Sponsor shall forthwith inform the 
competent authorities of those new events 
 
measures is the period from the time of signing of the ICF through the completion of the last 
 hours of becoming aware of the event. 
Examples 
following: 
 
 
 
s 

 
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11 
APPROPRIATENESS OF MEASUREMENTS
The measures of efficacy to be used in this study are standard, ie, widely used and generally 
recognized as reliable, accurate, 
laboratory procedures. 
The chromogenic substrate FVIII assay and the one-stage clotting FVIII assay are both 
v
for exploratory purposes only. 

 
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12 
STUDY PROCEDURES
12.1 
Prestudy 
re any study-related procedures are performed. 
12.2 
Screening Visit 
 days of BMN 
 days prior to BMN 
7 days prior to BMN 
 
occur within 30 days of the drug infusion, physical examination, vital signs, blood chemistry, 
LTs, hematology, urine tests, and coagulation tests do not need to be repeated at Baseline.  
The following procedures will be performed during the Screening Period: 
 
 
 Full medical history, including hemophilia A history, Hepatitis B, Hepatitis C, and 
HIV. Subjects with a history of hepatitis B or hepatitis 
obtained while the subject was receiving prophylactic or on-demand FVIII therapy 
prior to the study should also be collected. 
 Complete Physical Examination  
 Height and weight 
 
 
 Assessment of Adverse Events and Concomitant Medications 
 
cal 
 
o Further information on details to be included in documentation of previous 
bleeding episodes and FVIII usage, refer to the On Site File Binder. 
 Distribution of subject diaries and training in diary completion 
 Electrocardiogram 
 
 
 Samples for hFVIII Assays 
o Baseline FVIII activity – chromogenic substrate FVIII assay 
o Baseline FVIII activity level – one-stage clotting FVIII assay 

 
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o hFVIII 
 
o 
 
o 
 
o 
 
 
 
 
negative results 30 days prior to informed consent being obtained do not need to be 
rete
 
o Hepatitis B screening should include HBsAg, HBsAb, and HBcAb. 
 
Table 
 
 
Table 
 
Table 
.
 
 
12.2.1 “Smart Rescreening” Visit
Subjects who undergo smart rescreening must complete the rescreening assessments and 
 days of signing the original consent.  Subjects who do not 
 
-consent and undergo all screening 
procedures.  Subjects may not undergo smart rescreening more than once. 
If a patient has to be screened again because the original assessments have fallen out of the 
 
 
patient to be successfully re-screened for the study: 
 Vital signs
 Assessment of Adverse Events and Concomitant Medications 
 
 
 
 AAV5 Total Antibody assay 
 
Table 

 
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Table 
Table
.
12.3
Baseline Visit
procedures will be performed during the Baseline Period: 
Brief physical examination
Vital signs
Assessment of Adverse Events and Concomitant Medications 
Blood sample for AAV5 TI assay 
 Blood sample for AAV5 TAb assay 
Blood chemistry, hematology, and coagulat
Table
o ABO blood typing assessment should be performed at Baseline, or at 
another regularly scheduled visit prior to the end of the subject’s 
participation in the study. 
 
Table 
 
Table 
.
 
Samples for hFVIII Assays
o Baseline FVIII activity – chromogenic substrate FVIII assay 
o
Baseline FVIII activity level – one-stage clotting FVIII assay
o
hFVIII coagulation activity exploratory assay 
o 
 
o hFVIII total antibody assay 
o hFVIII protein assay 
 PBMC collection for CTL baseline 
 
 
 TGA Assay
 PCR of vector DNA in blood, saliva, urine, semen, and stools 
 
 Haemo-QoL-A assessment 

 
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 EQ-5D-5L 
ionnaire 
12.4
Treatment Visit/BMN 270 Infusion Visit (Day 1)
There will be one treatment visit for each subject.  Subjects will remain in the clinic for at 
 hours for the BMN 270 Infusion Visit.  The following procedures will be performed 
during the BMN 270 Infusion Visit: 
 Brief physical examination
 Assessment of Adverse Events and Concomitant Medications 
 AAV5 TAb 
-
 
-
 
o 
-infusion laboratory 
sampling on the day of the infusion visit. 
 BMN 270 Infusion 
 Vital Signs 
o Vital signs will be recorded prior to BMN 270 infusion and then every 
 
 270 infusion.  Following infusion, 
 hours during the subject’s stay in the clinic. 
 PCR of vector DNA in blood, saliva, urine, semen, and stools 
o Collection of samples for PCR testing should occur between 2 and 
 hours after the BMN 270 infusion has been completed 
In case of hypersensitivity or adverse drug reaction, safety assessment, including physical 
examination and vital signs, will be done and additional blood samples will be collected 
 C5, C5a, and 
-
after the reaction, if possible. In addition, a blood sample 
 
-patient observation 
can be extended and additional blood samples can be collected if deemed necessary at the 
discretion of the Investigator and Medical Monitor. 

 
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12.5 
BMN 270 Infusion Follow-Up Visits – Weeks 1-26 
 
 
-
-
participation in 270-
al MN services or shortened lab draw-only site visits may be 
MN 
MN services may be used if the subject is unable to attend the site to complete the study visit 
during the acceptable window for that visit, upon prior approval by the Medical Monitor and 
discussion between the Medical Monitor and Investigator. In the event that neither a lab-only 
visit or MN visit can be conducted, the site should telephone the subject to collect adverse 
 
 
planned, refer to Section 
 for assessments related to performing the liver biopsy. 
-
 
12.5.1 Once per week (Weeks 1 through 26)  
 
 Brief ph
 
 
o For visits where a MN service is being used or a lab draw-only site visit is 
conducted, physical examination will not be performed. 
 
uding review of 
 
o For visits where a MN service is being used, the service will contact the 
subject via e-mail or phone call to collect information regarding adverse 
events, changes to concomitant medications, bleeding episodes, and FVIII 
use. 
 Vital Signs 
o For visits where a MN service is being used or a lab draw-only site visit is 
conducted, vital signs will not be performed. 

 
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Table 
.
 
o 
ALT values are  
 
between the Medical Monitor and the Investigator and review of subject 
data, but LTs 
 Samples for FVIII Assays 
o 
 
o 
-
o FVIII coagulation activity exploratory assay 
o 
o FVIII protein assay 
12.5.2 Week 1 – Day 4 
 
 
ncluding review of 
 
 PCR of vector DNA in blood, saliva, urine, semen, and stools 
 
 Table 
.
 
12.5.3 Week 1 – Day 8 
 
: 
 PCR of vector DNA in blood, saliva, urine, semen, and stools 
12.5.4 Every 2 Weeks (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26) 
performed: 
 PBMC collection 
12.5.5 Weeks 2, 4, 10, 16, 22, and 26 
 
Table 

 
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12.5.6 Weeks 2, 3, 4, 6, 8, 12, 16, 20, 24, and 26 
 PCR of vector DNA in blood, saliva, urine, semen, and stools 
o Collection to occur until at least 3 consecutive results below the limit of 
detection are obtained.  Semen samples should continue to be collected 
below the limit 
of detection in that compartment have been recorded prior to that time 
point. 
12.5.7 Weeks 4, 12, and 26 
 
 Haemo-QoL-A assessment  
 EQ-5D-5L 
 HAL 
 
 
 PROBE 
12.5.8 Every 4 Weeks (Weeks 4, 8, 12, 16, 20, and 24) Plus Week 26 
following procedures will be performed: 
 
 FVIII antibody titer 
12.5.9 Every 8 Weeks (Weeks 8, 16, and 24) 
 AAV5 TAb assay
 AAV5 TI assay 
12.5.10 Weeks 6, 12, 16, 20, 24, and 26 
 
12.5.11Weeks 12 and 26 
 
 
Table 
 
 VWF:Ag 

 
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12.5.12 Week 16 
 
 
prior expos
 
o 
 
 
will be tested for hepatitis B and hepatitis C reactivation at the time points 
listed in Table
. 
12.5.13 Week 20, 24, and 26 
 
 TGA Assay
12.6 
Post-Infusion Follow-Up – Weeks 27-52 
 27-
 37-
 270-
participation in 270-
-only site visits may be 
 
esignated for 
MN 
MN services may be used if the subject is unable to attend the site to complete the study visit 
during the acceptable window for that visit, upon prior approval by the Medical Monitor and 
discussion between the Medical Monitor and Investigator. In the event that neither a lab-only 
visit or MN visit can be conducted, the site should telephone the subject to collect adverse 
event, concomitant medicati
 
planned, refer to Section 
 for assessments related to performing the liver biopsy. 
At these visits, the following procedures will be completed: 
12.6.1 Every Visit 
-
will be performed: 
 Physical examination 
o
 
 

 
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o For visits where a MN service is being used or a lab draw-only site visit is 
conducted, physical examination will not be performed. 
 
 
o For visits where a MN service is being used, the service will contact the 
subject via e-mail or phone call to collect information regarding adverse 
events, changes to concomitant medications, bleeding episodes, and FVIII 
use.
 Vital Signs 
o For visits where a MN service is being used or a lab draw-only site visit is 
conducted, vital signs will not be performed. 
 
Table 
.
 
o 
values are 
 
Medical Monitor and the Investigator and review of subject data, but LTs will 
is  
  
 
 FVIII Assays 
o 
 
o 
-
 
o FVIII coagulation activity exploratory assay 
o 
 
o FVIII protein assay  
12.6.2 Weeks 28, 32, 36, 44, and 52 
 
 PBMC collection 
12.6.3 Every 4 Weeks (Weeks 28, 32, 36, 40, 44, 48, 52) 
 
 Weight 
12.6.4 Weeks 32, 36, 44, and 52 
At 
 
 
Table 
 

 
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 FVIII antibody titer 
12.6.5 Weeks 32, 36, 40, 44, 48, and 52 
 
TGA Assay
PCR of vector DNA in blood, saliva, urine, semen, and stools 
o
Sample testing to occur until at least 3 consecutive sample results below the 
limit of detection have been obtained.  Subjects who have not had 
3 consecutive semen samples below the limit of detection
 52 should 
 
il 3 consecutive 
samples below the limit of detection 
 
12.6.6 Week 32, 36, and 52 
 
 AAV5 TAb Assay 
 AAV5 TI Assay
12.6.7 Week 36 and 52 
 
Table 
 VWF:Ag
12.6.8 Week 52 
, the following procedures will be performed: 
 Haemo-QoL-A assessment
 EQ-5D-5L 
 HAL
 
 PROBE
 
 
 
 

 
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12.7 
Post-Infusion Follow-Up – Years 2-5 
During Years 2-5, at applicable sites, certain study assessments may be performed by a 
their school or office, to improve access and convenience for patients participating in the 
study. The Sponsor may select a healthcare company that will be responsible for providing 
applicable regulations, and that appropria
investigator at a participating site determines that MN services are appropriate for a patient 
will communicate with the patient and the patient’s site. MN visits will be allowed for the 
-
visits during Years 2-5 will not be performed by an MN professional but will be done at the 
study site. 
unable to attend the site to complete the study visit during the acceptable window for that 
visit, upon prior approval by the Medical Monitor and discussion between the Medical 
Monitor and Investigator. 
failure to achieve FVIII activity  
from prophylactic FVIII replacement therapy due to joint bleeding episodes, in the judgment 
Monitor or Sponsor-designated Data Monitor, follow an abbreviated visit schedule after 
 
-5. 
-5 may receive a 
scheduled monthly follow-
  
Subjects who meet the definition of treatment failure and wish to follow an abbreviated 
schedule but who have not cleared vector shedding from all fluids must still provide samples 
-
vector shedding has cleared. Such subjects may provide samples on the designated study visit 
dates either at the sites or through use of a MN professional. 
During Years 2-5 of Post-Infusion Follow-up, the following procedures will be completed: 

 
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12.7.1 Year 2 – Every 4 Weeks (not required for treatment failure)
2 
 
 
 Table 
.
 
o 
are 
 baseline value or based upon discussion between the 
Medical Monitor and the Investigator and review of subject data. 
 FVIII Assays
o 
o 
-
 
o FVIII coagulation activity exploratory assay 
o 
 PCR of vector DNA in s
o Subjects who have not had 3 consecutive semen samples below the limit of 
detection 
 52 should continue to have PCR testing of semen every 
 2 until 3 consecutive samples below the limit of 
detection are documente
 
o Subjects who meet the definition of treatment failure and wish to follow 
an abbreviated schedule but who have not cleared vector shedding in 
semen must still provide semen samples for a
during Year 2 until vector shedding has cleared. Such subjects may 
provide samples on the designated study visit dates either at the sites or 
through use of a MN professional. 
12.7.2 Years 3-5 – Every 6 Weeks (not required for treatment failure)
During Years 3-
 
 
 
 
Table 
.
 
o 
 baseline value or based upon discussion between the Medical 
Monitor and the Investigator and review of subject data. 
 FVIII Assays

 
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o 
o 
-
 
o FVIII coagulation activity exploratory assay 
o 
o 
-5, a fresh sample should be collected within 
ve result. 
 
 
o Subjects who have not had 3 consecutive semen samples below the limit of 
detection by the end of Year 2 should continue to have PCR testing of semen 
-5 until 3 consecutive samples below the limit of 
detection 
 
o Subjects who meet the definition of treatment failure and wish to follow 
an abbreviated schedule but who have not cleared vector shedding in 
semen by the end of Year 2 must still provide semen samples for 
-5 until vector shedding has 
cleared. Such subjects may provide samples on the designated study visit 
dates either at the sites or through use of a MN professional.
12.7.3 Years 2-5 – Every 12 Weeks and End of Year Visits (required for all subjects)
During Years 2-
 
 
Year 2 – 
 Year 3 – 
 
 
– 
 
 Year 5 – 
 
 
 
not be performed remotely by MN services. 
 Physical examination 
o Complete physical examination will be performed at the End of Year 
examination may be performed at other visits. 

 
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Assessment of Adverse 
Table
.
o
are 
 baseline value or based upon discussion between the 
Medical Monitor and the Investigator and review of subject data. 
 FVIII Assays
o 
o 
-
 
o FVIII coagulation activity exploratory assay 
o 
o 
ears 3-5, a fresh sample should be collected within 
 
 FVIII protein assay  
 
Table 
 
 
Table 
 232, 
 Vital Signs 
 
visit for Years 3-
 
 
 FVIII antibody titer 
visit for Years 3-
 
 Haemo-QoL-
 232, and End 
 
 EQ-5D-
its 
 
 
 
 
 
 

 
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 Explorat
PBMC collection
VWF:Ag
o
Sample testing during Years 2-
3 consecutive samples are below the limit of detection in that matrix during 
the Post-Infusion Follow-
-52.  
o
Additional 
 
-
 for assessments related to 
 
12.8 
Early Termination Visit 
The Early Termination visit will occur on the date the subject withdraws from the study, even 
if the date does not correspond to a protocol-specific visit. 
If a subject
subject 
the study site and complete an Early Termination visit.  At the Early Termination visit, as 
many of the following assessments as possible should be done: 
 Physical examination 
 Weight 
 
 
 Vital Signs 
 
Table 
 
Table 
 
 Live
Table 
.
 
 FVIII Assays 
o 
 
o 
-
 
o FVIII coagulation activity exploratory assay 
o 
o FVIII protein assay  

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AAV5 TAb Assay
AAV5 TI Assay
FVIII antibody titer
PBMC collection
VWF:Ag
Liver ultrasound
PCR of vector DNA in blood, saliva, urine, semen, and stools
o
 consecutive samples
were clear during the Post-Infusion Follow-
Haemo-QoL-A assessment
EQ-5D-5L
HAL
PROBE
12.9 
Optional Liver Biopsy 
Table 
. 
during the Years 2-5 period post-BMN 270 infusion. 
Subjects consenting to participate to the optional liver biopsy will undergo pre-
biopsy 
 
Liver 
Physical examination
Hematology, coagulation, chemistry assessments
Liver tests
FibroScan
Subjects consenting to participate to the optional liver biopsy will undergo pre-
biopsy assessments 
 7 days before the procedure, as follows: 

 
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 Pre-
 
On the day of the biopsy, brief physical examination and liver and blood tests should be 
activity assessment should also be performed to ensure the subject has sufficient FVIII 
activity to protect against procedure-r
and a whole blood draw for PBMC collection should be performed on the biopsy day or 
  
 
The optional liver biopsy should be performed in the morning if feasible, and the biopsy 
procedure and follow-up care should be done according to the local standard of care. 
Additional details for handling the biopsy specimens are provided in the Laboratory Manual. 
Following completion of the biopsy, the subject should remain under observation in the clinic 
-
-procedure observation may be done at the investigator’s 
 
12.10 End of Study
The study will end after the last subject yet to complete the last Long-Term Follow-
 270 study, is withdrawn from the study, 
or discontinues from the study. BioMarin reserves the right to discontinue the study any time 
for clinical or administrative reasons and to discontinue participation of an individual 
Investigator or site for clinical or administrative reasons, including, but not limited to, poor 
enrollment or noncompliance with procedures of the protocol or GCP. In addition, the study 
may be terminated if, in the opinion of BioMarin, the safety of the study subjects may be 
compromised. 

 
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13 
DATA QUALITY ASSURANCE
BioMarin personnel or designees will visit the study site prior to initiation of the study to 
review with the site personnel information about the IP, protocol and other regulatory 
irements, 
and procedures for reporting AEs, including SAEs.  
At visits during and after the study, a CRA will monitor the site for compliance with 
regulatory documentation, with a focus on accurate and complete recording of data on eCRFs 
from source docume
and drug accountability records.  
predefined analysis plan. 

 
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14 
STATISTICAL METHODS AND DETERMINATION OF SAMPLE SIZE
Additional statistical information for the 2-
25
rotocol. 
14.1 
Statistical and Analytical Plans 
 
14.1.1 Interim Analyses 
Two interim analyses were 
-negative 
 
 
on the interim results and the totality of the data, the secondary interim analysis was deemed 
unnecessary. The DMC reviewed the interim analysis results to assess the efficacy and safety 
profiles, whether the pre-specified criteria of statistical significance has been achieved, and 
 270 studies based on the totality of the 
data. 
The primary efficacy endpoint for the interim analyses involves hFVIII activity, as measured 
by chromogenic substrate assay, achieved post-BMN 270 infusion.  
Wiens 2005
-
-year analysis at 
 
lanned to continue upon the 
-
 52 and the 2-year analysis at 
 
. 
The secondary and tertiary endpoints will be summarized descriptively at the interim 
 
The details of the interim analyses, including the control of Type I error rate, will be 
specified in the SAP. 
14.1.2 Procedures for Accounting for Missing, Unused and Spurious Data
Because the completeness of the data affects the integrity and accuracy of the final study 
analysis, every effort should be made to ensure complete, accurate, and timely data collection 
and, therefore, avoid missing data. 

 
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Missing data imputation and sensitivity analyses to assess the impact of missing data on the 
primary and secondary efficacy endpoints analyses are described in the following sections. 
Additional details regarding the handling of missing data will be provided in the SAP.
14.2 
Primary Efficacy Endpoint 
-52 post-BMN 270 infusion from baseline, as measured by chromogenic substrate 
-sample t-test will be used to test the null hypothesis that the change is 0 or less 
against the alternative hypothesis that the change is greater than 0. Descriptive summaries of 
-
to select thres
proportions will also be provided. 
For a subject with a missing value of the primary endpoint, the median value in the subject’s 
-
be used. Additional analyses will be 
conducted to examine the sensitivity of the results to the handling of missing data, including 
Further detail will be provided in the SAP. 
The analyses for the primary endpoint will be performed using the analysis populations as 
defined in Section 
. 
14.3 
Secondary Efficacy Endpoints 
 subjects in 
 months in the 
non-interventional study 270-
-
will be derived from the prospectively collected data in 270-
 
For the first-
on 
 
-sample t-test will be performed to test the null 
hypothesis that the change is 0 or greater against the alternative hypothesis that the change is 
less than 0. The missing value of the change will be imputed as 0.  
For the second-
-sample t-test will 
be performed to test for non-inferiority of BMN 
baseline ABR calculated using subjects’ data collected as part of 270-
non-inferiority margin of 3.5, ie, to test the null hypothesis that the change is 3.5 or greater 
against the alternative hypothesis that the change is less than 3.5.  If non-inferiority is 

 
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demonstrated, the test for superiority of BMN 270 against FVIII prophylaxis will be 
performed. The missing value of the change will be imputed using the median value of the 
changes of all observed cases. 
A sensitivity analysis is planned to analyze ABR using a generalized linear mixed model 
assuming negative binomial as the underlying distribution. The model will include period 
- to post-
implemented as the offset. 
To assess the impact of missing data, analyses using observed case are planned as sensitivity 
analyses for the secondary endpoints.  Multiple imputation methods may also be performed. 
The primary and secondary efficacy hypotheses will be tested hierarchically according to the 
order described above. Multiple comparison procedures will be described in greater detail in 
the SAP.
14.4 
Liver Biopsy Substudy Analysis 
A separate report presenting and discussing analyses of the exploratory objectives for the 
optional liver biopsy substudy will be prepared. 
14.5 
Immunogenicity 
Analysis of total and neutralizing antibody response and other immunological parameters 
will be primarily descriptive and involve both inter-subject and intra-subject comparisons.  
14.6 
Pharmacodynamic Analyses 
Plasma FVIII protein concentrations and FVIII activities determined over the course of the 
study will primarily be evaluated and summarized with descriptive statistical measures 
 
 
14.7 
Safety Analysis 
the Sponsor to assign system organ class and preferred term classification to events and 
diseases, based on the original terms entered on the eCRF.
All AEs will be coded using the current version of MedDRA. The incidence of AEs will be 
summarized by system organ class, preferred term, relationship to study drug, and severity. 
A by-
including death, or experience an AE associated with early withdrawal from the study or 
study drug.  

 
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Clinical laboratory data will be summarized by the type of laboratory test. For each clinical 
visits. Descriptive statistics for physical examination results and vital signs will also be 
provided.  
Detailed statistical methods will be provided in the SAP. 
14.8 
Determination of Sample Size 
size for this study is based on clinical and statistical considerations in order to provide 
sufficient data to assess both safety and efficacy of BMN 270. 
 
-52 from baseline is greater 
than 0, assuming an effect size 
-sample t-test with a 2-sided significance 
Study 270-
Study 270-
 
-wee
  
For the secondary endpoints, the analysis will be performed utilizing exogenous FVIII use 
and bleeding ep
-interventional study 270-
enrollment in Study 270-
wer 
g one-sample t-test 
with a 2-sided significance level of 0.05. 
For the analytic sample size calculation of the second-
assumed that the pre- and post-BMN 270 infusion population mean ABRs are 3.5 and 
respectively, and the distribution of ABRs is negative binomial distribution with a 
dispersion parameter of 2.2. Given the underlying negative binomial distributions, the 
standard deviations of the pre- and post-
- to post-BMN 270 infusion 
ABRs are calculated as -
- and post-BMN 270 

 
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at le
-inferiority 
-sample t-test with a 2-
the change is less than 0, ie, superiority of BMN 270 against FVIII prophylaxis. 
-year analysis with a 2-sided 
significance level of 0.05. 
14.9 
Analysis Populations 
The intention-to-trea
 270 
infusion, and the modified intention-to-
receive BMN 270 infusion and are HIV-negative. The mITT population will be used for the 
primary efficacy analysis and ITT will be used for the supportive efficacy analysis. The ITT 
population will also be used for the safety analysis. 
14.10 Changes in the Conduct of the Study or Planned Analyses 
Only BioMarin may modify the protocol. Any change in study conduct considered necessary 
by the Investigator will be made only after consultation with BioMarin, who will then issue a 
formal protocol amendment to implement the change. The only exception is when an 
Investigator considers that a subject’s safety is compromised without immediate action. In 
B within 
2 
 
must review and approve all protocol amendments. Protocol amendments that have an impact 
 
burden to subjects, the ICF will be amended and approved by BioMarin and the 
 
If discrepancies exist in statistical methods between the SAP and the study protocol, the SAP 
will prevail. 

 
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15 
DATA MONITORING COMMITTEE 
An independent DMC will be convened for this study.  The duties of the DMC will include: 
 Conducting an ongoing review of individual subject safety and efficacy data during 
the study. 
 
 based on emerging data from 270-
analysis of BMN 270. 
 Reviewing ongoing safety and efficacy data for comparability of drug manufacturing 
lots within 270-
and between 270-
-
. 
 
recommendations on the conduct and reporting of the trial based on 
their evaluation of clinical data.
functions and parameters are included in the DMC Charter and in the Statistical Analysis 

 
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16 
COSTS, COMPENSATION, AND SUBJECT INJURY 
BioMarin will pay the full costs of the study-related tests, procedures, and treatments set 
he 
reasonable cost of travel for study-related visits in accordance with BioMarin’s travel and 
reimbursement policy. 
The Investigator should contact BioMarin immediately upon notification that a study subject 
has been injured by the study drug or by procedures performed as part of the study. 
Any subject who experiences a study-related injury should be instructed by the Investigator 
-specified medical institution if possible, or at 
the closest medical treatment facility if necessary. The subject should be given the name of a 
study-related injuries. BioMarin or the institution may pay for reasonable and necessary 
medical services to treat the injuries caused by the study drug or study procedures. In some 
jurisdictions, BioMarin is obligated by law to pay for study-related injuries. If this is the case, 
BioMarin will comply with the law. BioMarin will not pay for any hospitalizations, tests, or 
treatments for medical problems of any sort related solely to the study subject’s primary 
disease or any concurrent disease and that are unrelated to this study. 

 
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17 
CASE REPORT FORMS AND SOURCE DOCUMENTS
Electronic case report forms will be provided for each subject. The Investigator must review 
 
eCRFs must be completed using a web–based application developed and validated. Study site 
personnel will be trained on the application and will enter the clinical data from source 
acceptable. 
In the event of an entry error, or if new information becomes available, the value will be 
corrected by deselecting the erroneous response and then selecting or entering the factual 
 CFR Part 
The documented audit trail will include the reason for the change, the original value, the new 
value, the time of the correction and the identity of the operator. 
BioMarin’s policy is that study data on the eCRFs must be verifiable to the source data, 
which necessitates access to all original recordings, laboratory reports, and subject records. 
therefore agree to allow direct access to all source data. Subjects must also allow access to 
their medical records, and subjects will be informed of this and will confirm their agreement 
when giving informed consent. If direct source document verification of study data by the 
site monitor is prohibited by institutional policy o
-compliant source verification to occur. 
Examples of such methods include certified copies of records which have study data visible 
but sensitive information redacted, or other GCP-compliant means agreed between the 
Investigator and the Sponsor. 
A site monitor designated by BioMarin will compare the eCRFs with the original source 
documents at the study site and evaluate them for completeness and accuracy before 
de
correcting the data or 
–
have been answered and closed.  

 
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source data verified.  The Investigator 
that the information on the eCRFs is accurate and complete. The Data Manager, or designee, 
completion of the CSR, 
 

 
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18 
STUDY MONITORING AND AUDITING
Qualified individuals designated by BioMarin will monitor all aspects of the study according 
to GCP and standard operating procedures for compliance with applicable government 
regulations. The Investigator agrees to allow these monitors direct access to the clinical 
supplies, dispensing, and storage areas and to the clinical files, including original medical 
The Investigator and staff are responsible for being present or available for consultation 
during routinely scheduled site visits conducted by BioMarin or its designees. When in 
person site monitoring or source data verification cannot be conducted, remote site 
 
Members of BioMarin’s GCP Compliance Department or designees may conduct an audit of 
a clinical site at any time before, during, or after completion of the study. The Investigator 
Representatives of the FDA or other Regulatory Agencies may also conduct an audit of the 
study. If informed of such an inspection, the Investigator should notify BioMarin 
immediately. The Investigator will ensure that the auditors have access to the clinical 
supplies, study site facilities, original source documentation, and all study files. 

 
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19 
RETENTION OF RECORDS 
regulations in a secure and safe facility. The Investigator must consult a BioMarin 
representative before disposal of any study records, and must notify BioMarin of any change 
ature destruction of essential documents, that is, 
documents that individually and collectively permit evaluation of the conduct of a study and 
as well as any or
 
 pending or contemplated 
should retain subject identifiers for at lea
years. 
These documents should 
maintenance of subj
 

 
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20 
USE OF INFORMATION AND PUBLICATION 
BioMarin recognizes the importance of communicating medical study data and therefore 
encourages the publication of these data in reputable, peer-reviewed scientific journals and at 
seminars or conferences. The details of the processes of producing and reviewing reports, 
manuscripts, and presentations based on the data from this study will be described in the 
 

 
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21 
REFERENCES 
 update on terminology and reporting.  Am J 
-
Bedossa P, Pynard T, French METAVIR Cooperative Study Group.  An algorithm for 
-
Berntorp E, Dolan G, Hay C, Linari S et al. European retrospective study of real-life 
-
 
-
 
-72. 
Chai-
EuroQol Group.  EuroQol – a new facility for the measurement of health-
-
-
-
Grant A, Neuberger J, Day C, Saxseena S. British Society of Gastroenterology Guidelines on 
-guidelines-on-the-use-of-liver-biopsy-in-clinical-
practice.html 
 
Hay CR, DiMichele DM. The principal results of the International Immune Tolerance Study: 
a randomized dose comparison 
-
 
Haemo-
manual. 
 
World Federation of Hemophilia. Establishing the Prevalence and Prevalence at Birth of 
Hemophilia in Males: A Meta-
ntern Med. 
-
 

 
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hemophilia 
-
Manno CS, Pierce GF, Arruda VR, Glader B et. al. Successful transduction of liver in 
hemophilia by AAV-
-
 
escalating study in adult patients with haemophilia B with AMT-
-hF
-
-
: Clinical and Research 
Information on Drug-
 
-term safety and efficacy of 
-
Nathwani AC, Rosales, C, McIntosh J, Rastegarlari G et. al. Long-term safety and efficacy 
following systemic administration of a self-complementary AAV vector encoding human 
-
-up of AAV5-hFVIII-SQ 
-
 
f normal factor VIII activity following 
- term efficacy and safety 
 
Reilly M. WPAI Scoring. 2002. Available at: htt
 
Recht M, Neufeld EJ, Sharma VR, Solem CT et al.  Impact of Acute Bleeding on Daily 
Activities of Patients with Congenital Hemophilia with Inhibitors and Their Caregivers and 
Fami
Value 
-
 
Rentz A, Flood E, Altisent C, Bullinger M et al. Cross-cultural development and 
psychometric evaluation of a patient-reported health-
-
 

 
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Sampson HA, Muñoz-Furlong A, Campbell RL, et al. Second symposium on the definition 
and management of anaphylaxis: summary report—second National Institute of Allergy and 
-
 
-
-
for Adults 
 
Van Genderen FR, Westers P, Heijnen L, 
on their functional abilities: validation of the Haemophilia Activities List.  Haemophilia.  
-
 
hypotheses. J 
–

 
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22 
INVESTIGATOR RESPONSIBILITIES 
22.1 
Conduct of Study and Protection of Human Patients  
ensure that: 
 He or she will conduct the study in accordance with the relevant, current protocol and 
necessary to protect the safety, rights, or welfare of subjects. 
 He or she will personally conduct or supervise the study. 
 He or she will inform any potential subjects, or any persons used as controls, that the 
drugs are being used for investigational purposes, and he or she will ensure that the 
 
section
 
 He or she will report to the sponsor adverse experiences that occur in the course of 
the 
 He or she has read and understands the information in the Investigator’s Brochure, 
 
 His or her staff and all persons who assist in the conduct of the study are informed 
about their obligations in meeting the above commitments 
 
 
nce with 
 
 
 
Section 3.0, and other applicable regulations, and conducts initial and ongoing 
reviews and approvals of the study. He or she will also ensure that any change in 
ry to eliminate 
apparent immediate hazards to human subjects. 
 
 

 
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24 
APPENDIX 1: SAMPSON’S ANAPHYLAXIS CRITERIA
inition and 
one of the following 
3 criteria are fulfilled: 
ruritus or flushing, 
swollen lips-tongue-
AND AT LEAST ONE OF THE FOLLOWING
a.
-bronchospasm, stridor, 
 
b. 
-organ 
 
2. Two or more of the following that occur rapidly after exposure to a likely allergen for 
that patient
 
a.
-
, itch-flush, 
swollen lips-tongue-
 
b. 
-bronchospasm, stridor, 
 
c. 
 
d. 
 
3. Reduced BP after exposure to known allergen for that patient 
 
a.
b. Adults: 
that person’s baseline. 
Source: 
. 

 
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25 
APPENDIX 2: REGION-SPECIFIC STUDY OBJECTIVES, ENDPOINTS, 
AND ANALYSES (“2-YEAR ANALYSIS”) FOR THE UNITED STATES 
BioMarin to submit 2-year safety and efficacy data on all subjects in 270-
being the primary efficacy endpoint. This section specifies region-specific study objectives 
and the associated endpoints and analyses to achieve them in order to fulfill this regulatory 
-
 
This 2-year analysis does not affect the study sample size, study conduct, and data collection. 
25.1 
Region-Specific Study Objectives 
 Primary efficacy objective 
o 
ng exogenous FVIII replacement 
data cut-off for the 2-year analysis following intravenous infusion of 
BMN 
 
 Secondary efficacy objectives 
o 
following intravenous infusion of BMN 270 
o 
usage of exogenous FVIII replacement therapy in the efficacy evaluation 
 
 Tertiary efficacy objective 
o 
patient-
 
infusion of BMN 270 
 Safety objectives 
o 
intravenous infusion of BMN 270  
o To assess the long-term safety of BMN 270 

 
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 Exploratory objectives of the liver biopsy substudy 
o To examine the histopathology of the liver following BMN 270 therapy, 
o 
es
o To determine which forms of rAAV vector DNA are present at the time of 
biopsy 
o To determine the distribution of BMN270-transduced hepatocytes in 
-
25.2 
Region-Specific Study Endpoints 
 Primary efficacy endpoint 
o 
prophylaxis
 Secondary efficacy endpoints  
o 
post-BMN 270 infusion 
o 
exogenous FVIII 
 
 Tertiary efficacy endpoints 
o Change from baseline in the total score of Haemo-QoL-
the study post-BMN 270 infusion 
o Change from baseline in the EQ-5D-
 
post-BMN 270 infusion 
o
 
-
BMN 270 infusion  
o
 
study post-BMN 270 infusion 
o
Change from baseli
 
-
BMN 270 infusion 

 
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 Safety endpoints 
o Incidence of AEs and SAEs  
o 
o Change in vital signs 
o Change in physical examination  
o 
 
o 
 
o Immune response to FVIII transgene product and AAV5 capsid proteins 
25.3 
Statistical Methods for the Analysis of Region-Specific Endpoints  
25.3.1 Statistical Analysis Plan
endpoints of the 2-
additional details on these analyses, as well as the planned supportive, sensitivity, and 
subgroup analyses and analyses for the other endpoints.  
If discrepancies exist in statistical methods between the SAP and the study protocol, the SAP 
will prevail. 
25.3.2 Timing of Analysis 
The 2-year analysi
t was 
dosed with BMN 270.   
25.3.3 Data to be Included in the Analysis 
All safety and efficacy data through each subject’s last visit up to the analysis data cutoff 
date will be included in the analysis.  
25.3.4 Analysis Populations 
Subjects will be analyzed in the following analysis populations: 
 Intent-to-
l subjects who received BMN 270 infusion in 
270-
 
 Modified Intent-to-
infusion in 270-
-negative at study screening. 

 
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Study 270-
participation in the BioMarin-sponsored non-interventional study 270-
enrolling in 270-
-negative at study screening, and received BMN 270 
infusion in 270-
 
 Directly Enrolled Subjects: subjects who were enrolled in 270-
participation in 270-
-
 
 Directly Enrolled, HIV-Negative Subjects: subjects who were directly enrolled in 
270-
-negative at study screening. 
The 270-
sed for the primary analysis of the primary efficacy 
-
-
secondary efficacy endpoint 
primary analysis of safety. 
25.3.5 Interim Analyses and Control of Type I Error Rate 
Prior to this 2-year analysis, two protocol-
-year analysis 
were planned, of which 
-year analysis were performed. 
-negative 
respectively. The concept of the interim analyses was to facilitate initiation of regulatory 
primary efficacy endpoint was subject’s FVIII response status, where a subject was 
considered as a responder if the median FVIII activity per chromogenic assay during 
 23-
-
were allocated to the first and second interim analysis, respectively. The second interim 
the pre-
-year analysis was planned 
-
reated bleeds, 
-
on. These endpoints were 
Wiens 2005
-wise type I error rate at 0.05. Results 

 
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from this analysis were intended to support regulatory submissions to EMA and other health 
authorities outside of FDA. 
-
-
on the 
-specified 
-year analysis was 
-
-BMN 270 infusion. Results from all pre-specified tests were 
 
 If the first interim p-
 significant and 
the -year analysis is carried out at the 0.05 level. 
 If the first interim p-
sult is not declared significant 
and the second interim
-
 significant and the -year 
  
 If the second interim p-
-
 
-
that a 2-year final analysi
-year analysis will 
be extended to the 2-year final analysis. That is, when all pre-specified tests are statistically 
-year analysis, the corresponding efficacy endpoints at 2 years will be 
-year analysis, the 2-year final 
ill 
 
 For non-inferiority of BMN 270 versus FVIII prophylaxis in ABR with a NI margin 
of 3.5 
Null hypothesis: post-baseline ABR – 
 
2. For superiority of BMN 270 versus no treatment for severe hemophilia A in FVIII 
activity 
– 
 
3. For superiority of BMN 270 versus FVIII prophylaxis in FVIII utilization 
           Null hypothesis: post-baseline FVIII utilization – 
 

 
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 For superiority of BMN 270 versus FVIII prophylaxis in ABR 
Null hypothesis: post-baseline ABR – 
 
After the 2-year final analysis, safety and efficacy will then continue to be assessed long-
term in all subjects for a total of approximately 5 years. 
25.3.6 Analysis Methods 
Primary Efficacy Endpoint 
The primary efficacy endpoint is change from baseline in ABR for treated bleeds.  
The primary analysis of the primary efficacy endpoint will be based on the 270-
Subjects. The baseline ABR under FVIII prophylaxis will be based on the data collected in 
270-
-BMN 270 infusion will be based the data collected in the efficacy 
evaluation perio
date. 
Change from baseline in ABR will first be tested for non-inferiority with a NI margin of 3.5 
using the confidence interval approach. Assuming a t distribution, the 2-sid
-baseline - 
ABR. If the upper bound of the CI is less than 3.5, the non-inferiority of BMN 270 versus 
FVIII prophylaxis in ABR with this margin will be declared. 
If non-inferiority is demonstrated, non-inferiority with smaller margins and superiority will 
be assessed using the same CI. The 2-sided p-value for superiority will be obtained through a 
one-sample t-test to test the null hypothesis that the change is 0 or greater. 
A Wilcoxon signed-
sensitivity analyses for testing superiority in ABR.  
First-
The first-
 FVIII activity, as 
-BMN 270 infusion.  
The primary analysis of the first-
mITT population. The baseline FVIII activity value will be imputed as 
-BMN 
270 infusion will be excluded from analysis if obtain
random fluctuation, FVIII activity will be analyzed as the median of observed values in the 

 
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visit windows as defined in Se
-year analysis SAP. Missing data will be 
imputed as follows: 
 Dropout missing  
o For subjects who discontinue from the study early, missing FVIII activity 
values post-
cutoff date for the analysis.
 Intermittent missing 
o 
non-missing value and the next non-missing value. In rare cases where the 
next value is unavailable for a subject who did not drop out, the missing 
value will be imputed through linear extrapolation using the last two prior 
non-missing values. 
A one-sample t-test will be used to test the null hypothesis that the change in FVIII activity 
- 
provided for descriptive purposes. 
A complete case 
superiority.  
Additional details about the sensitivity analyses as well as the missing data imputation will 
be provided in the 2-year analysis SAP.
Second-
The second-
annualized 
 
The primary analysis of the second-
270-
based on the data collected in 270-
-BMN 270 infusion will be 
last visit up to the analysis data cutoff date. 
A one-sample t-test will be used to test the null hypothesis that the change from baseline in 
-baseline - 
, 

 
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purposes. 
Safety Endpoints 
Analysis of safety endpoints will be descriptive.  
The incidence of AEs will be summarized by system organ class, preferred term, relationship 
to study drug, seriousness, and severity. A by-subject listing will be provided for subjects 
who experience a SAE, including death, or experience an AE associated with early 
withdrawal from the study. Clinical laboratory test values, vital signs, vector shedding and 
immune response parameters will be summarized descriptively by visit. 
Additional details on the primary analysis of the key efficacy and safety endpoints, as 
well as the planned supportive, sensitivity, and subgroup analyses and analyses for the 
other endpoints will be provided in the 2-year analysis SAP. 

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26 
PROTOCOL AMENDMENT TEXT REVISIONS 
The following table summarizes the revisions made to the protocol and 
 2-
Added text is indicated by underlined font and deleted text is indicated by 
 font. 
Section No./Title
Revision
Rationale
 
BMN 270 is being evaluated in clinical study 270-
-in-
subjects with severe HA designed to assess the safety and efficacy of BMN 
ically, 270-
augmentation of residual FVIII activity and whether these levels are sufficient to alter the clinical phenotype. 
PreliminaryFour-year results from 270-
-
-year results from 270-
 have demonstrated that following 
gene transfer, mean and median FVIII activity levels 
range for FVIII, is
achievable with a doseand sustained following 
a single infusion of -
of BMN 270, with an acceptable safety profile
. Preliminary results from 
optional liver biopsies confirm dose-dependent pan-lobular and otherwise healthy liver transduction at 2.7-
 
psis 
 
The secondary efficacy objectives of the study are to: 
Assess the impact of BMN 270 on usage of exogenous FVIII replacement therapy 
in 
-year analysis, hereafter 
 
 
therapy from 
Last Vi
 
The aforementioned study efficacy objectives were achieved through the pre-
-year 
-
submissions to EMA and other health authorities outside of FDA.
-year safety and efficacy data on all subjects in 270-
benefit-
region-
-
from the study.
3
 
The final -year analysis for the study will be was performed after all subjects have had been followed for 52
post-BMN 270 infusion. A separate 2-
-BMN 270 infusion. After the final analysis -year and the 2-year analyses, 
safety and efficacy will then continue to be assessed long-term in all subjects for a total of approximately 5 years.
3, 7, 
, 
 

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Section No./Title
Revision
Rationale
either failure to achieve FVIII 
or and inability to maintain independence from prophylactic FVIII replacement therapy 
r 
discussion with the Medical Monitor or Sponsor-designated Data Monitor, follow an abbreviated visit schedule after 
-5. 
 
An optional liver biopsy will be performed as part of the liver biopsy substudy 
-
-5 following BMN 270 infusion. Subjects 
who consent to the liver biopsy will have additional assessments, including a liver ultrasound and FibroScan, and will 
receive prophylactic FVIII prior to the procedure, as if indicated in the judgment of the Investigator, to minimize the 
 Additional liver biopsies may be performed as part of the substudy during Years 2-5 as clinically 
indicated.
 
Secondary efficacy endpoints:  
exogenous FVIII replacement therapy during in the efficacy 
-BMN 270 infusion
 from the baseline utilization 
of exogenous FVIII replacement therapy. 
Change
annualized bleeding rate, 
during 
 52 of the 
study post-BMN 270 infusion
from the baseline ABR. 
3 
 
Sample Size
For the secondary endpoints, the analyses will be performed utilizing exogenous FVIII use and bleeding episode data 
-
interventional study 270-
-
ement 
therapy during 
-BMN 270 infusion
 from 
-sample t-test with a 2-sided significance level of 
0.05. 
An analytic samp
during in the efficacy evaluation 
st-BMN 270 infusion
from the baseline ABR is less than 3.5 
-
- and post-BMN
respectively, using a one-sample t-test with a 2-sided significance level of 0.0
3, 

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Section No./Title
Revision
Rationale
, superiority of BMN 
270 against FVIII prophylaxis. 
Analysis 
For the first-
 secondary efficacy endpoint 
of exogenous FVIII replacement therapy 
5-52 post-BMN 270 
a one-sample t-test will be performed to test the null hypothesis that the change 
is 0 or greater against the alternative hypothesis that the change is less than 0.  
For the second-
 secondary efficacy endpoint 
 
er of bleeding 
 5-52 post-BMN 270 infusion from 
a one-sample t-test will be performed to test for 
non-inferiority of 
in 270-
hypothesis that the change is less than 3.5. If non-inferiority is demonstrated, the test for superiority of BMN 270 
against FVIII prophylaxis will be performed. 
 
, and the final the 
-year
, and the 2-
interim analyses results, the study is 
planned to continue for a total of approximately 5 years upon the DMC’s recommendation, and the final analysis will 
 
 At the final -year 
 and the 2-
, the secondary 
-
Nathwani, 
Studies 
Study Ongoing clinical studies for BMN 270 include:
270-
is an ongoing, a
-escalation study to assess the safety, tolerability, and efficacy of 
BMN 270 in patients with severe 
HA
270-203, a phase 2 study in patients with severe HA who have anti-AAV5 antibody titers
270-
FVIII 
Subjectsinhibitors
270-
270-303, a phase 3 study in patients with severe HA who received a single BMN 270 infusion and are to be 
dose 
at the
dose level along with prophylactic corticosteroids

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Section No./Title
Revision
Rationale
 
PreliminaryFour-year results from 270--
mean and median FVIII 
activity levels 
measured by a 
chromogenic substrate assay, are achievable with a doseand sustained following a single infusion of -
of 
BMN 270, with an acceptable safety profile 
 
receiving lower doses of BMN 270 in 270-
-dependent pan-lobular and otherwise healthy liver 
transduction at 2.7-
 For additional information on preliminary data in 270-
the Investigator’s Brochure. 
 
Benefits 
e injury or liver 
dysfunction. In almost all subjects, ALT elevations 
differences in the use of corticosteroids across studies. Subjects in 270-
we
-
significant decline in FVIII activity concurrently with an ALT elevation, and saw a more robust recovery of FVIII 
activity upon the first use of corticosteroids, than did the subjects in the mITT population in 270-
 
by FVIII activity levels were found to be temporally associated with anti-AAV5 antibody or cellular immune 
responses.
-
-
-
elevation about 5.5 
-
steroids was being 
 
-
-
-
attributed to the difference in the protocol-specified corticosteroid regimens in place in those studies, including the 
-
rapidly to corticosteroids, given current interest in the field of AAV gene therapy for the use of non-steroidal 
approaches to managing or preventing ALT elevations, alternate non-steroidal systemic immunosuppressive agents 
have also been used to manage hepatic reactions where corticosteroids have proven to be ineffective or where high 
experience with BMN 270 suggests that transient elevations in liver enzymes are expected following AAV-based gene 
therapy for the treatment for hemophilia A or B without any long-
In 270-
vity in the majority of subjects to mild HA or normal 
-
-study rates and the ability 
to discontinue prophylactic FVIII infusions. All subjects who will bewere included in the final -year analysis have 

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Section No./Title
Revision
Rationale
 
The secondary efficacy objectives of the study are to: 
 
Assess the impact of BMN 270 on usage of exogenous FVIII replacement therapy 
in 
-year analysis, hereafter 
 
Ass
therapy from 
 52
 
The aforementioned study efficacy objectives were achieved through the pre-
-year 
-
submissions to EMA and other health authorities outside of FDA.  
-year safety and efficacy data on all subjects in 270-
 to enable their 
benefit-
region-
analy
-
from the study.
3
 
Design and Plan 
The final -year analysis for the study will be was performed after all subjects have had been followed for 52
post-BMN 270 infusion. A separate 2-
-BMN 270 infusion. After the final analysis -year and the 2-year analyses, 
safety and efficacy will then continue to be assessed long-term in all subjects for a total of approximately 5 years.
either failure to achieve FVIII 
orand inability to maintain independence from prophylactic FVIII replacement therapy 
discussion with the Medical Monitor or Sponsor-designated Data Monitor, follow an abbreviated visit schedule after 
 
 2-5. 
An optional liver biopsy will be performed as part of the liver biopsy substudy 
-
-5 following BMN 270 infusion. Subjects 
who consent to the liver biopsy will have additional assessments, including a liver ultrasound and FibroScan, and will 
of bleeding. Additional liver biopsies may be performed as part of the substudy during Years 2-5 as clinically 
indicated.
3, 7, 
, 
 

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Section No./Title
Revision
Rationale
-
 
 
 
 
ETV: Early Termination Visit 
a Complete physical examination should be performed at the End of Year visits  
 
visit each year and at every End of Year visit during Years 2-5. 
b Refer to Table
for laboratory assessments to be included, and to Table
for liver tests. LTsLT 
assessment may be monitored
 more or less 
when ALT values are  
 
 baseline value  or based onupon discussion between the Medical Monitor and the Investigator and review of 
. 
Subjects with ALT  
 baseline value during the study and either an alternative etiology considered or 
or ultrasound, additional blo
 
 
 values from prior assessment are accompanied by declines in 
after a discussion between the Medical Monitor and the Investigator based on a review of 
subject data. 
If 
activity and ALT levels may be adjusted based on discussion between the Medical Monitor and the Investigator. 
During Years 2-5 of the Post-Infusion Follow-
nd blood, chemistry, and coagulation tests should 
c 
-
and coagulation exploratory assay, and hFVIII protein assay. 
If a subject has used FVIII within 72 hours of a measurement day, all efforts should be made to obtain FVIII activity 
measurements when a 72-hour 
-hour wash-out period is only intended for 
 270 infusion and who have not resumed FVIII 
replacement therapy. If FVIII levels are elevated or stab
activity may be adjusted based on discussion between the Medical Monitor and the Investigator. A D-dimer may be 
considered under circumstances in which FVIII activity levels are above the normal phys
-
 
sitive 
result. 
dd
2, and then at End of Year Visits during Years 3-5.
 

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Section No./Title
Revision
Rationale
e
5 End of Year Visit, or at 
 
eg 
ransfer, and to develop assays used for these evaluations.  Subjects may 
 samples will be collected at the time points indicated 
TGA assay and any other 
performed only as deemed necessary by the Sponsor.
gi
Additional liver ultrasounds may be 
discretion of the Investigator. 
h  
An optional liver biopsy may be performed at any time between Years 2-5 of the study. The optional biopsy 
may be triggered by a FVIII activity de
-state, over 2 consecutive measurements, or by a 
 hours prior to liver ultrasound and optional liver biopsies. More than one liver biopsy 
may be performed during this period, as clinically indicated. 
 
b Following initiation or completion of steroid regimen, if a recurrence of ALT values 
baseline value 
is reported, steroid management decisions will based on discussions between the Investigator and Medical Monitor.  
on 
possible confounders for the ALT elevation, 
levels post steroid initiation, and adverse events related to steroid dosing. Guidance for tapering oral corticosteroid 
dosing can be found in Section
5 
Study Design, 
including Choice of 
Control Group 
270 dose. Subjects will initially be followed for 
52
-BMN 270 infusion, 
After the final
-
year analysis atfor the study will be performed after all subject have been followed for
-BMN 270 
infusion. A separate 2-year analysis will also be performed per
-BMN 270 infusion.
-year analysis and the 2-year analysis, safety and efficacy 
will then continue to be assessed long-term in all subjects for a total of approximately a total of 5 years. During 
enrollment, the DMC will review available safety and efficacy data on an ongoing basis and may decide to recommend 
-
r 
 
3, 
Concomitant 
Medications 
The following medications are prohibited starting 30 days before Screening and through the end of the study, and the 
Sponsor must be notified if a subject receives any of these during the study: 
Any investigational therapy other than BMN 270

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Section No./Title
Revision
Rationale
Administration of SARS-CoV-2 vaccine after BMN 270 infusion may occur after consultation between Investigator 
and Medical Monitor. 
 
Hemophilia 
Treatments 
Subjects on prophylactic FVIII therapy will discontinue their regular 
of infusion and switch to an “on-demandepisodic
 
Steroids for Elevated 
LTs 
TherapeuticReactive
n either of the 
following occurs post-BMN 
 
 
 baseline value in 2 consecutive assessments within 72 hours and alternative etiologies 
have been 
 
Table 7
3.2
 
o
Whenever possible, a confirmatory lab draw for ALT should be performed, along with FVIII activity, 
prior to initiating reactive oral corticosteroids. 
o 
reactive corticosteroids may be clinically indicated, a discussion 
Management of ALT elevations with reactive corticosteroids, including tapering of doses and managing worsening 
hould be guided by the following Table
The prescribed regimen for 
5, 
Management of ALT 
Elevations with 
Reactive 
Corticosteroids 
 
5, 
 

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Steroids for Elevated 
 
When ruling out alternative viral or autoimmune 
Table
 
and Autoimmune 
Hepatitis Testing 
 
 
Steroids for Elevated 
 
After discontinuation of reactive 
Following initiation or completion of therapeuticreactive oral corticosteroid
 
ible 
confounders for the ALT elevation and impact on FVIII expression.   
HIV Positive Subjects 
HIV-positive subjects who have previously enrolled in 270-
-
prescribed and 
 
. 
 
In the event of an FVIII activity level decline during the study:
consecutive assessments, FVIII activity and LTs should be repeated every 7 days until FVIII activity is stable 
or increasing
consecutive assessments, 
FVIII activity and LTs should be repeated every 72 hours until FVIII activity is stable or increasing
Note that fluctuations in FVIII activity after gene therapy are common, and if no clear trend indicating a decline in 
monitoring of FVIII activity levels is 
not needed 
in the absence of a concurrent or recent ALT elevation or upon consultation between the Investigator and the Medical 
Monitor
r trend of decline has been demonstrated or until the FVIII activity levels stabilize or 
increase. 
either failure to achieve FVIII 
orand inability to maintain independence from prophylactic FVIII replacement therapy 
discussion with the Medical Monitor or Sponsor-designated Data Monitor, follow an abbreviated visit schedule after 
 
 2-5. 
7, 

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Section No./Title
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Bleeding Episodes 
Secondary efficacy variables are: 
 
during in the efficacy 
from the baseline utilization of 
exogenous FVIII replacement therapy. 
 
Change 
during 
 270 infusion
 
from the baseline ABR.  
ity documented historical data available concerning previous bleeding episodes and 
 months in order to be eligible to enroll in the study. During the study, 
use of factor replacement therapy and the number of bleeding 
episodes since the previous visit. This information will be captured on the subject’s diary or other subject records. 
Subjects will be encouraged to discuss any bleeding episodes with the Investigator and attempt to objectively assess 
any reported bleeds through use of ultrasound or non-invasive imaging. 
3, 
 
Biopsy 
may be pursued. at any time during Years 2-5. 
performed during the study. 
Liver ultrasounds will be performed annually at each End of Year visi
of the study to screen for HCC. Additional liver ultrasounds may be performed between the End of Year visits at the 
discretion of the Investigator. 
-
-
ed during the course 
of the study. The study site will coordinate sending samples from the malignancy for genomic analyses, if available.
Hepatitis Testing 
following plan
outlined in Table
scheduled laboratory tests may be completed by a mobile nursing professional at sites 
where the use of MN services has been approved  
Table 9.7.8.3.2 and Table 9.7.8.3.3 were relocated to Section 9.4.8.2 (as mentioned above).
 
Physical Exam, and 
Other Safety 
A complete physical examination will 
. The 
-related 
complaints.

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Section No./Title
Revision
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-5 – 
 
 
 
Physical examination 
o 
Complete physical examination will be performed at the End of Year visits  
examination may be def
brief physical examination may be performed at other visits.
Table
o
LTsLT assessment may be monitored
when ALT 
values are  
 baseline value  or based onupon discussion between the Medical 
Monitor and the Investigator and review of subject data, but LTs will be monitored at least twice 
. 
AAV5 TAb Assay
nd of Year visit for Years 3-
AAV5 TI Assay
FVIII antibody titer
-
TGA Assay
o 
Additional liver 
 
Termination Visit 
At the Early Termination visit, as many of the following assessments as possible should be done: 
TGA Assay
Liver ultrasound
 
and Determination of 
Sample Size 
Additional statistical information for the 2-
this protocol.
Analyses 
, 
, the 
final -year
, and the 2-
interim analyses results, the 
study is planned to continue upon the DMC’s recommendation
At the final -year
52 and the 2-
, the secondary efficacy endpoints will be 
tested hierarchi
3
Efficacy Endpoints 
For the first-
secondary efficacy endpoint 
of exogenous FVIII replacement therapy 
5-52 post-BMN 270 
infusion
-sample t-test will be performed to test the null hypothesis that the change 
3 

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is 0 or greater against the alternative hypothesis that the change is less than 0. The missing value of the change will be 
imputed as 0.  
For the second-
 
, annualized bleeding rate, 
  
5-52 post-BMN 270 infusion 
 
one-sample t-test will be performed to test for non-inferiority of BMN
ABR calculated using subjects’ data collected as part of 270-
using a non-inferiority margin of 3.5, ie, to test the 
null hypothesis that the change is 3.5 or greater against the alternative hypothesis that the change is less than 3.5. 
Sample Size 
For the secondary endpoints, the analysis will be performed utilizing exogenous FVIII use and bleeding episode data 
-
interventional study 270-
-
 
therapy during 
-BMN 270 infusionLa
 from the 
-sample t-test with a 2-sided significance 
level of 0.05. 
For the analytic sample size calculation of the second-
secondary endpoint, ABR, it is assumed that the pre- and 
post-
 respectively, and the distribution of ABRs is negative 
binomial distribution with a dispersion parameter of 2.2. Given the underlying negative binomial distributions, the 
standard deviations of the pre- and post-
- to post-BMN 270 infusion ABRs are calculated as -
between pre- and post-BMN 270 i
during in the e
 52 of the 
study post-BMN 270 infusion
-
-
sample t-test with a 2-
 270 against FVIII 
prophylaxis. 
ry efficacy 
endpoints hierarchically at the final -year analysis with a 2-sided significance level of 0.05. 
3, 
Conduct of the Study 
or Planned Analyses 
If discrepancies exist in statistical methods between the SAP and the study protocol, the SAP will prevail.
and Auditing 
Qualified individuals designated by BioMarin will monitor all aspects of the study according to GCP and standard 
operating procedures for compliance with applicable government regulations. The Investigator agrees to allow these 
monitors direct access to the clinical supplies, dispensing, and storage areas and to the clinical files, including original 

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Revision
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tors. The Investigator and staff are 
responsible for being present or available for consultation during routinely scheduled site visits conducted by BioMarin 
or its designees. When in person site monitoring or source data verification cannot be conducted, remote site 
 
Haemo-
Last accessed 
.  
Hemophilia. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males: A Meta-analytic Approach 
-
 
-
 
Mitchell N, Lester W et al. Achievement of Normal Circulating Factor VIII Activity 
Following BMN 270 Multiyear Follow-up of AAV5-FVIIIhFVIII-SQ Gene Transfer: Interim, Long-Term Efficacy and 
Therapy for Hemophilia A. 
-
. 
Last accessed 
.  
Srivastava A, 
-
et. al. WFH
guidelines for the management of hemophilia
, 3rd edition. Haemophilia
. 2
-
-
. 
Panel on Antiretroviral Guidelines for Adults and 
Adolescents. 
HIV- -Infected Adults and Adolescents
with 
Available at
-and-adolescent-arv-
-hiv- -rna--viral-load--and-
-count-monitoring. 
last accessed 
July
Printed name:
Adebayo LawalTara Robinson, MD, MSc, MBA, SeniorPhD, Associate Medical Director, Clinical 
Sciences
-
-Year 
has been added as part of this protocol amendment.