Non-Interventional Study on the Tolerability and Efficacy of IVIG
Conditions: Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG
Sponsor: Octapharma

 
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090-CTP-GAM10-06-06.docx 
 
OBSERVATIONAL PLAN 
 
 
NON-INTERVENTIONAL STUDY ON THE TOLERABILITY OF 
IVIG AND SCIG 
 
GAM10-06 
 
"GammaTrack" 
 
 
 
 
 
 
 
Octapharma AG 
Seidenstrasse 2 
8853 Lachen 
Switzerland 
 
 
 
Version: 
06 
 
Dated: 
27-June-2018 
 
Replaces: 
Version 05, dated 18-September-2017 
 
 
 
 

 
 
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PROTOCOL AUTHORIZATION 
 
This observational study will be conducted in compliance with the protocol,  
and applicable regulatory requirements. 
 
 
Sponsor Representatives: 
 
 
_____
___ 
Qualified Person for Pharmacovigilance 
Octapharma Pharmazeutika Produktionsges.m.b.H. 
Vienna, Austria 
 
 
______
_ 
 
Vice President and Head Global Medical & Scientific Affairs  
Octapharma Pharmazeutika Produktionsges.m.b.H. 
Vienna, Austria 
 
 
 

 
 
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TABLE OF CONTENTS 
 
OBSERVATIONAL PLAN ................................................................................................................ 1 
Table of Contents ................................................................................................................................ 3 
List of Abbreviations ........................................................................................................................... 4 
1 
Introduction ................................................................................................................................. 4 
1.1 
Background ................................................................................................................... 4 
2 
Objectives ................................................................................................................................... 5 
3 
Investigational Plan ..................................................................................................................... 6 
3.1 
Overall Design and Plan ............................................................................................... 6 
3.1.1 
Population ................................................................................................. 6 
3.1.2 
Centres ...................................................................................................... 6 
3.1.3 
Flowchart of Study Events ........................................................................ 6 
3.1.4 
Study Duration .......................................................................................... 7 
3.1.5 
Premature Termination .............................................................................. 7 
4 
Treatment .................................................................................................................................... 8 
4.1 
Observational Drugs ..................................................................................................... 8 
4.2 
Concomitant Treatments ............................................................................................... 9 
5 
Safety Monitoring ....................................................................................................................... 9 
5.1 
Adverse drug reaction ................................................................................................... 9 
5.2 
Other Relevant Drug Safety Information .................................................................... 10 
5.3 
Reporting of ADRs and other Safety Information ...................................................... 11 
5.4 
Laboratory Investigations ........................................................................................... 11 
6 
Statistical Considerations .......................................................................................................... 11 
7 
Data Handling and Record Keeping ......................................................................................... 11 
7.1 
Electronic Case Report Forms .................................................................................... 11 
7.2 
Investigator Site File ................................................................................................... 12 
7.3 
Data Protection ........................................................................................................... 12 
7.4 
Final Report ................................................................................................................ 12 
8 
General Information .................................................................................................................. 13 
 
 
 
 
 

 
 
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LIST OF ABBREVIATIONS 
ADR 
Adverse Drug Reaction 
eCRF 
Electronic Case Report/Record Form 
EDC 
Electronic Data Capturing 
EMA 
European Medicines Agency 
IVIG 
Intravenous Immunoglobulin 
NIS 
Non-Interventional Study 
PASS 
Post-Authorisation Safety Surveillance 
PID 
Primary Immunodeficiencies 
SCIG 
Subcutaneous Immunoglobulin 
S/D 
Solvent/Detergent 
SID 
Secondary Immunodeficiencies 
SmPC 
Summary of Product Characteristics 
TNBP 
1 
INTRODUCTION 
1.1 
BACKGROUND 
Since more than six decades immunoglobulins have been used to provide antibodies for 
the 
prevention 
of 
viral 
and 
bacterial 
diseases 
(replacement 
therapy) 
in 
immunocompromised patients. In the earlier years (around 1950), the IgG preparations 
were administered intramuscularly. This route of administration causes substantial 
discomfort, and restricts the amount of IgG that can be given to the patients. Since its use 
as a replacement therapy for patients with primary (PID) and secondary (SID) 
immunodeficiencies, the clinical use of intravenous immunoglobulin (IVIG) has 
expanded and has become an important treatment option in a wide spectrum of diseases. 
IVIG is used routinely in autoimmune and acute inflammatory conditions due to IVIG’s 
immune-modulatory and anti-inflammatory properties. During the last 25 years, the use 
of subcutaneously administered immunoglobulins (SCIG) has further contributed to the 
successful treatment of PID and SID patients. Administration via the SC route offers 
several advantages over IV infusion from a patient’s and a physician’s perspective and 
therefore became an alternative treatment option to IV treatment. After introduction of 
small, portable syringe drivers, SCIG products have gained even more popularity in 
Europe,  USA, and Canada as a practical, effective and safe treatment, as they can be 
safely self-administered at home or even when travelling. 
octagam® 5% and octagam® 10% are liquid polyvalent IVIG preparations, which are 
subject to a three-stage viral inactivation. The products are prepared from human plasma 
and mainly contain human normal immunoglobulin G. The molecules are present in their 
native form which is essential for the biological activity. octagam® 5%, has been approved 
in 83 countries worldwide since 1995; octagam® 10% has been approved in 58 countries 
worldwide since 2008. 

 
 
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octagam® is produced from a pool of at least 3,500 donations of human fresh frozen 
plasma per batch.1 The large donor pool ensures that the product contains a broad range 
of antibodies directed against pathogens and foreign antigens, which is far more diverse 
than that of plasma from an individual donor. Donor plasma sampling, the manufacturing 
of the product and the measures to ensure the product's viral safety are subject to strict 
regulations laid down by regulatory authorities. Octapharma exclusively uses plasma that 
has been tested by nucleic acid testing (NAT) techniques. The production process 
contains three validated virus inactivation steps (modified ethanol fractionation, pH 
treatment, and solvent/detergent (S/D) virus inactivation). 
panzyga® (Immune Globulin Intravenous (Human), 10%) is a sterile liquid preparation of 
highly purified immunoglobulin G (IgG) derived from large pools of human plasma. The 
panzyga® manufacturing process achieves a significant viral reduction through a 
combination of two dedicated manufacturing process steps: S/D treatment and 
nanofiltration (20 nm). The Source Q chromatography (ion-exchange chromatography) 
step in the panzyga® process also contributes significantly to the viral safety of panzyga®. 
The efficacy of the virus inactivation procedures has been extensively validated. 
panzyga® has been approved in 29 countries worldwide since 2016. 
cutaquig® is a sterile solution of human normal immunoglobulin containing 16.5% (165 
mg/mL) protein for SC administration, prepared from at least 3500 donations of human 
fresh-frozen plasma. Effective viral reduction is obtained via a combination of 3 validated 
manufacturing steps: cold-ethanol fractionation, S/D treatment with TNBP (Tri-n-butyl 
phosphate) and Octoxynol, and pH 4 treatment. cutaquig® has been approved in Canada. 
This post-marketing surveillance study is designed to ensure long-term consistency 
between data from the pre-licensure clinical studies and clinical use. Documentation of 
the administration of Octapharma’s IVIG products (octagam®, panzyga®) and the newly 
licensed SCIG product (cutaquig®) in clinical practice will not only improve the efficacy 
and tolerability knowledge database, but will produce findings that cannot be obtained in 
the same way in controlled clinical studies. This surveillance study will support the 
optimal use of octagam®, panzyga®, and cutaquig®, thus bringing benefit for both 
physicians and patients.  
 
2 
OBJECTIVES 
1) The primary objective is to document the safety and tolerability of octagam®, 
panzyga® and cutaquig® in any indication, age group or treatment regimen. 
2) The secondary objective is to document their efficacy in patients receiving treatment.  
 
                                                 
1 For simplicity, the term octagam® refers in this document, to both strengths (5% and 10%) unless noted 
otherwise. 

 
 
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3 
INVESTIGATIONAL PLAN 
3.1 
OVERALL DESIGN AND PLAN 
This is a prospective, multicentre, non-interventional study (NIS). 
The treating physician decides whether, how and for how long a patient is to be treated 
with octagam®, panzyga®, and/or cutaquig®. 
 
3.1.1 
Population 
octagam®, panzyga®, and/or cutaquig® will be prescribed regularly to any patient who 
needs to be treated with an IgG product because of their medical condition and whom the 
treating physician wants to include in this observational study, after the decision has been 
made to prescribe IVIG or SCIG treatment. 
This study will observe 300–500 patients treated with octagam®, panzyga® and/or 
cutaquig® in any indication, age group, gender or treatment regimen. It is not possible to 
specify the exact number of doses per patient that are to be documented because of the 
different indications for use. 
All patients who are eligible to enter the study will be informed by the physician before 
study entry about the conduct, implication and goal of this Post-Authorisation safety 
Surveillance. This will be done following center internal procedures. Each patient is 
uniquely identified in the study by an ID number that will be provided by the study centre 
to ensure patient confidentiality. Once assigned to a patient, a patient number will not be 
reused nor will the patient be allowed to re-enter the study after completion or 
discontinuation. 
3.1.2 
Centres 
This observational study is conducted in outpatient and inpatient centres globally.  
3.1.3 
Flowchart of Study Events 
Due to its non-interventional and observational nature, this study will strictly exclude pre-
defined visits or time schedules (except that a close-out visit should take place before a 
patient leaves the NIS). However, it is recommended to perform subsequent visits on 
regular intervals according to standard treatment procedures for the respective disease. 
Table 1 lists all assessments recommended by this protocol. 
Table 1: Assessment schedule  
Assessments 
Baseline or 
Entry Visit 
Subsequent 
Infusion Visits 
Close-Out 
Visit 
Baseline assessments 
 
 
 
Previous 
IVIG 
and 
SCIG 
treatments 
 
 
 
Concomitant medication(s) 
 
 
 

 
 
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octagam®/panzyga® /cutaquig® 
treatment details 
 
1 
 
Information on efficacy 
 
 
 
Adverse drug reactions (ADRs) 
 
1 
 
Checking of patient diary for 
patients doing cutaquig® home 
treatment 
 
 
 
1 May take place at the same day as baseline/entry visit. 
Data obtained during the study will be recorded, for this purposeElectronic case report 
forms (eCRF), namely a secure web-based data entry system (see Section 7.1), will be 
used. 
 
The eCRF will consist of 4 main sections: 
1) Baseline documentation: Must be completed when a new patient is enrolled. The 
patient’s demographic data (year of birth or age, gender, weight, general condition, 
risk factors), medical history, basic disease (including date of diagnosis and details 
on previous treatments), and concomitant medications and diseases are to be 
documented. 
2) Treatment record: Treatment details with octagam®/panzyga®/cutaquig® are to be 
documented, including date of administration, method of administration, infusion 
speed, dosage, batch number, concomitant medications incl. treatment details, if 
applicable. In case of home treatment with cutaquig®, patients will be asked to fill in 
a study diary to carefully document information (ie. including date and method of 
administration, infusion speed, dosage, batch number; concomitant medications incl. 
treatment details, if applicable).  
3) Suspected 
ADRs 
occurring 
during 
or 
after 
administration 
of 
octagam®/panzyga®/cutaquig® are to be recorded on separate ADR forms. Patients are 
to be advised to document in their diaries every ADR they experience at home, also 
in case they do not need any medical treatment. 
4) Efficacy assessment: Available efficacy data are to be documented. 
3.1.4 
Study Duration 
This study started in August 2011 in 4 European countries and was then extended to 
Canada. The European centres are now closed or being closed and the study will continue 
in Canada. Planned study end is 2022. 
The duration of observation for an individual patient will be as long as any of the 
described IVIGs or the SCIG will be prescribed by the treating physician and until the 
next regularly scheduled visit of the patient after last infusion. For patients with PID or 
SID the observation period should last at least 12 months, if possible. 
3.1.5 
Premature Termination 
If, for any reason, the physician or the patient decides to discontinue treatment with 
octagam®, panzyga® or cutaquig®, the observation period of this patient is to be 

 
 
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terminated and a close-out visit should take place. The physician should make efforts to 
complete and document all available observations. The reason for termination is to be 
documented. 
If the reason for discontinuing octagam®, panzyga® or cutaquig®therapy is the occurrence 
of an ADR, the specific reaction must be recorded and the outcome is to be documented. 
4 
TREATMENT 
4.1 
OBSERVATIONAL DRUGS 
Subjects documented in this NIS will receive commercially available octagam®, 
panzyga® or cutaquig® prescribed by a physician. 
octagam® 5% contains 50 mg protein per mL of solution of which ≥ 95% is IgG; the IgA 
content is ≤0.2 mg/mL and IgM content is ≤0.1 mg/mL. octagam® 10% contains 100 mg 
protein per mL of solution of which ≥ 95% is IgG; the IgA content is ≤0.4 mg/mL and 
IgM content is ≤0.3 mg/mL. All four IgG subclasses are present in proportions 
corresponding to the normal physiological distribution. The product is liquid, contains 
maltose and has undergone multiple virus inactivation procedures. 
panzyga® is a 10% solution ready for intravenous administration. panzyga® is made from 
a pool of at least 1000 donations of human fresh-frozen plasma per batch. During the 
manufacturing process of panzyga®, significant viral reduction is obtained via a 
combination of different validated steps during the manufacturing process. The efficacy 
of the virus inactivation procedures has been extensively validated according to relevant 
international guidelines in place. 
cutaquig® is a sterile solution of human normal immunoglobulin containing 16.5% (165 
mg/mL) protein, prepared from at least 3,500 donations of human fresh-frozen plasma 
per batch. Effective viral reduction is obtained via a combination of three validated 
manufacturing steps. The manufacture of cutaquig® is based on the octagam® 
manufacturing process including an additional adsorption step onto a commercially 
available and widely used chromatography column for the removal of coagulation factor 
XI (FXI). The process is identical up to the step of diafiltration. 
octagam® 5% can be stored for 2 years at a temperature of +2 °C to +25 °C. octagam® 
10% can be kept refrigerated at +2 °C to +8 °C for 2 years but can also alternatively be 
stored for 9 months at room temperature, in which case the end date automatically 
becomes the expiry date. panzyga® can be stored at +2 °C to +8 °C for 24 months from the 
date of manufacture. Within this shelf-life the product may be stored up to 9 months at ≤ 
25°C. After the storage at ≤ 25°C the product must be used or discarded. cutaquig® can be 
stored for 2 years at +2 °C to +8 °C. Within this shelf-life the product may be stored up to 6 
months at ≤ 25°C and must be used or discarded within that period. 
Patients are treated with octagam®, panzyga® or cutaquig®according to the Investigator’s 
prescription. For dosage recommendations please refer to the local octagam®, panzyga® 
or cutaquig®package leaflets. 
Dosage and duration of treatment is at the sole discretion of the Investigator and will 
depend on the type and/or severity of the disease and the patient’s clinical condition. 

 
 
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In case of SCIG home treatment the Investigator should promote compliance by 
instructing the patient to take cutaquig® exactly as prescribed and by stating that 
compliance is necessary for the patient’s safety. The patient should be instructed to 
contact the Investigator if he/she is unable for any reason to administer cutaquig® as 
prescribed. 
All dosages of octagam®, panzyga® or cutaquig® that a patient received during the 
observation period at the study center are to be recorded on the corresponding eCRF 
pages. Dosages of cutaquig® that a patient administered during the observation period at 
home are to be recorded in the patient diary and will be entered into the eCRF later. It is 
of utter importance that all data entered into the diary are checked by the Investigator for 
completeness and any safety-relevant issues (including infusion site reactions) during 
each patient’s visit to the study center. 
Any drug dose adjustment and interruptions should be recorded on the corresponding 
eCRF page. 
If, for any reason, the Investigator or the patient decide to discontinue the treatment with 
octagam®, panzyga® or cutaquig®, the observation period of this patient will be 
terminated. Efforts should be made to arrange a close-out visit. The reason(s) for 
termination in the eCRF is to be documented. Switching from one Octapharma Ig product 
to another Octapharma Ig product is possible without termination of the study but should 
be documented. 
4.2 
CONCOMITANT TREATMENTS 
Any other concomitant treatments are at the Investigator's discretion and need to be 
documented in the eCRF or the patient diary and transferred later into the eCRF. 
The Investigator should instruct the patient to notify the site about any new medications 
he/she takes after starting this observation. 
5 
SAFETY MONITORING 
To allow continuous monitoring of the product safety all adverse drug reactions (ADRs) 
and other safety-relevant information as defined below are to be documented. 
5.1 
ADVERSE DRUG REACTION 
An ADR is any noxious and unintended response to the study drug which occurs at doses 
normally used in humans for the prophylaxis or therapy of disease or for the restoration, 
correction or modification of physiological function. Response in this context means that 
a causal relationship between the study drug and an adverse event (AE) is at least a 
reasonable possibility. 
 
Serious ADR 
A serious ADR is any untoward medical occurrence that is considered related to study 
drug and that at any dose: 
• is resulting in death; 

 
 
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• is life-threatening ("life-threatening" means that the patient was at an immediate 
risk of death at the time of the event; it does not mean a hypothetical situation of 
what could or would have happened if, for example, no treatment had been 
administered); 
• requiring 
hospitalisation 
or 
prolongation 
of 
existing 
hospitalisation 
(hospitalisation does not refer to the treatment of an ADR on an out-patient status); 
• resulting in persistent or significant disability/incapacity; 
• is a congenital anomaly/birth defect; 
• is any other important medical event (e.g. suspected transmission of an infectious 
agent, or other reactions that should be reported in an expedited manner although 
they did not immediately result in one of the above seriousness criteria). 
 
Medical judgment should be exercised in deciding whether an ADR is serious in other 
situations: Important ADRs that are not immediately life-threatening or do not result in 
death or hospitalization but may jeopardize the patient or may require intervention to 
prevent one of the other outcomes listed in the definitions above, should also be 
considered serious. 
Causality assessment of cases should follow the WHO-UMC causality categories: 
https://www.who-umc.org/media/2768/standardised-case-causality-assessment.pdf 
 
5.2 
OTHER RELEVANT DRUG SAFETY INFORMATION 
The following events should also be reported: 
a) pregnancies/breastfeeding; 
b) drug abuse (persistent or sporadic, intentional excessive use of a medicinal 
product, which is accompanied by harmful physical or psychological effects), 
misuse; 
c) overdose (treatment exceeding the medically recommended dose); 
d) medication errors (prescribing or dispensing error); 
e) interaction(s) with other medicinal product or device; 
f) suspected transmission of infectious agent; 
g) off-label use; 
h) occupational exposure; 
i) lack of efficacy; 
j) quality complaints with harm (or potential harm) of the patient. 
This information should be reported if associated with the use of octagam®, panzyga® 
and/or cutaquig®or – in case of pregnancy/breastfeeding – if observed during treatment 
with octagam®, panzyga® and/or cutaquig®. 
Above mentioned events should also be recorded if no ADR occurred. 

 
 
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In the eCRF specific pages are included for data entry for ADRs and infusions site 
reactions. 
5.3 
REPORTING OF ADRS AND OTHER SAFETY INFORMATION 
All ADRs and other safety information as defined above have to be documented on the 
specific electronic forms of the electronic data capturing (EDC) system. 
Serious ADRs have to be entered immediately (within 24 hours) into the eCRF and should 
be transferred electronically to Octapharma.  
Non-serious ADRs and other safety information should be reported upon recognition but 
no later than 10 days. 
Patients undergoing home treatment should be asked to inform their treating physician 
immediately of any ADR, or other relevant safety information. The treating physician 
will assess the causal relationship for ADR and report the event as described above. 
Octapharma will handle all ADRs as post-marketing safety reports and will report the 
cases in compliance with applicable regulations for pharmacovigilance. 
 
5.4 
LABORATORY INVESTIGATIONS 
The type and timing of blood sampling for laboratory evaluations are at the full discretion 
of the responsible physician. If such blood sampling takes place, only abnormal and 
clinically significant abnormal parameters should be documented in the eCRF. 
6 
STATISTICAL CONSIDERATIONS 
Statistical analysis of all parameters will be descriptive. SAS software will be used for 
the statistical analysis. All data will be listed in their entirety and will be presented in 
summary tables. 
In general, all study parameters will be described using the following standard statistical 
parameters: arithmetic means, standard deviation, median, minimum and maximum. 
Frequency tables (absolute and relative frequencies) will be produced for categorical 
parameters.  
The demographic data, indications for use, baseline values, and number of doses will be 
summarised descriptively. Tolerability and efficacy assessments made by the treating 
physicians will be presented by frequency tables and corresponding figures. 
7 
DATA HANDLING AND RECORD KEEPING 
7.1 
ELECTRONIC CASE REPORT FORMS 
An electronic case report form (eCRF) at the sites via a web-based secure and validated 
EDC system will be used for each patient enrolled. Investigators and study nurses are 
allowed to enter or change data in the eCRF as long as they are registered on a Delegation 
of Authority Log. Access to the eCRF is made only via a compatible web browser 
(Internet Explorer or Firefox). Internet is required. All safety relevant information will be 
transferred electronically to Octapharma's Corporate Drug Safety Unit.  

 
 
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Monitors and data management will have access to the data in the eCRF without the 
possibility to modify data. They are able to create queries. Investigators need to reply to 
given queries in the eCRF. Data will be checked for plausibility and completeness. 
Investigators must provide missing or non-plausible data in the eCRF. 
At the end, the Principle Investigator will electronically sign the eCRF. The eCRF pages 
that have been locked will be printed and stored in the Investigator's archives for at least 
as long as required by regulatory constraints after completion or discontinuation of the 
trial, together with the original informed consent forms (if applicable) and the patient 
identification list. The Sponsor will archive the whole eCRF database. 
 
7.2 
INVESTIGATOR SITE FILE 
The Investigator is responsible for maintaining all adequate records to enable the conduct 
of the project to be fully documented. This includes, among others, this protocol and any 
subsequent amendments, a sample of the eCRF, all correspondence pertaining to the 
conduct of the project, other written information, financial aspects of the project, signed 
agreement between involved parties, a copy of the notification to competent authorities, 
ethics committees or hospital administration, if applicable. 
The Investigator is responsible for maintaining a confidential patient identification code 
list which provides the unique link between named source records and eCRF data. The 
Investigator must arrange for the retention of this confidential list for the maximum period 
of time required by local regulations. 
No study document should be destroyed without prior written agreement between the 
Investigator and the Sponsor. Should the Investigator elect to assign the study documents 
to another party, or move them to another location, the Sponsor must be notified in 
writing.  
7.3 
DATA PROTECTION 
In accordance with applicable regulations, all patient data documented on the eCRFs are 
to be pseudo-anonymised by the treating physician. Only the treating physician, or a 
person authorised by the treating physician, will be able to decode the patient identity 
using an internal patient allocation list. 
Informed consent for the inclusion of a patient into this non-interventional study may or 
may not be required depending on the country; signing of a data privacy statement maybe 
sufficient for most countries. However, the treating physician is advised to always inform 
the participating patient about their inclusion in this NIS and the use of their pseudo-
anonymised data in reports. This process should be documented in the patients' records. 
If requested by national regulations governing the performance of non-interventional 
clinical studies, this NIS protocol (and any other documentation to be provided to patients, 
like patient diaries) has to be submitted to the Ethics Committee in charge for the 
hospital/institution where the NIS is conducted. 
7.4 
FINAL REPORT 
At the end of the NIS, a final report will be compiled within 1 year. 

 
 
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8 
GENERAL INFORMATION 
The observational study is registered on clinicaltrial.gov under number NCT02303093.  
For any questions relating to the observational study please contact: 
Local Octapharma contact and/or central study team in Vienna: 
 
 
Local Canadian Octapharma contact: