Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A

Study Overview
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Brief Summary
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The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity, and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to severe hemophilia A.

Official Title
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Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A

Conditions
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Hemophilia A

Intervention / Treatment
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* Biological: Octocog alfa (recombinant human coagulation factor VIII)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously untreated patient (PUP) in China with moderate to severe hemophilia A. Investigator prescribed ADVATE as the predominant therapeutic agent for the management of hemophilia A Informed consent form from patient and/or legal representative will need to be signed per local regulation Exclusion Criteria: Presence of an inherited or acquired hemostatic defect other than hemophilia A, and any other clinically significant chronic disease Participants who participated in another investigational FVIII drug study, or had participated in any clinical study involving an investigational FVIII drug during the course of the observation period
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Previously Untreated Patients (PUPs)<br>PUPs in China with Moderate to Severe Hemophilia A | Biological: Octocog alfa (recombinant human coagulation factor VIII)<br> <br> * Other names: plasma/albumin-free method (rAHF-PFM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of high titer, low titer and transient Factor VIII (FVIII) inhibitors developed |  | Throughout the study period of 6 months | 
| Number and type of other serious and non-serious adverse events (AEs) | Other AEs refers to AEs other than Factor VIII (FVIII) inhibitors | Throughout the study period of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and type of bleeding episodes treated with ADVATE |  | Throughout the study period of 6 months | 
| Number of bleeding episodes treated with 1, 2, 3, ≥ 4 infusions of ADVATE |  | Throughout the study period of 6 months | 
| Annualized bleeding rate (ABR) of participants treated prophylactically and on-demand with ADVATE |  | Throughout the study period of 6 months | 
| Annualized joint bleeding rate (AJBR) of participants treated prophylactically and on-demand with ADVATE |  | Throughout the study period of 6 months | 
| Total number of exposure days (EDs) to ADVATE |  | Throughout the study period of 6 months | 
| Total units of ADVATE administered |  | Throughout the study period of 6 months | 
| Total number of exposure days (EDs) to all Factor VIII (FVIII) products |  | Throughout the study period of 6 months | 
| Total units of all Factor VIII (FVIII) products administered |  | Throughout the study period of 6 months |