ADYNOVATE Drug Use-Results Survey

Study Overview
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Brief Summary
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The purpose of this survey is to understand the following items in the actual clinical use of ADYNOVATE in patients: Unexpected adverse drug reactions Occurrence of adverse drug reactions in the actual clinical use Factors that may affect safety and efficacy Occurrence of Factor VIII inhibitor development in patients with coagulation factor VIII deficiency (hereinafter hemophilia A) Safety and efficacy for hemophilia A patients who received routine prophylactic therapy and on-demand therapy

Official Title
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ADYNOVATE Drug Use-Results Survey

Conditions
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Hemophilia A

Intervention / Treatment
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* Biological: ADYNOVATE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemophilia A patients who receive ADYNOVATE, including previously treated patients with Factor VIII deficiency (PTPs), and previously untreated patients with Factor VIII deficiency (PUPs) who are treated with ADYNOVATE. Exclusion Criteria: Patients not administered ADYNOVATE.
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 treated patients (PTPs)<br>PTPs: patients who had 4 or more days to other Factor VIII (FVIII) products | Biological: ADYNOVATE<br>* Antihemophilic Factor (Recombinant), PEGylated<br>* Other names: Recombinant Factor VIII (FVIII) PEGylated;|
| Previously untreated patients (PUPs)<br>PUPs: patients who had 3 or less previous exposure days to other products | Biological: ADYNOVATE<br>* Antihemophilic Factor (Recombinant), PEGylated<br>* Other names: Recombinant Factor VIII (FVIII) PEGylated;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants who discontinued the use of ADYNOVATE - previously treated patients (PTPs) | Number of PTPs who discontinued the use of ADYNOVATE | Throughout the study participation period: 1 year for previously treated patients (PTPs) | 
| Participants who discontinued the use of ADYNOVATE - previously untreated patients (PUPs) | Number of PUPs who discontinued the use of ADYNOVATE | Throughout the study participation period: 2 years for previously untreated patients (PUPs) | 
| Participants who developed a Factor VIII (FVIII) inhibitor - previously treated patients (PTPs) | Number of PTPs who developed a Factor VIII (FVIII) inhibitor | Throughout the study participation period: 1 year for previously treated patients (PTPs) | 
| Participants who developed a Factor VIII (FVIII) inhibitor - previously untreated patients (PUPs) | Number of PUPs who developed a Factor VIII (FVIII) inhibitor | Throughout the study participation period: 2 years for previously untreated patients (PUPs) | 
| Annual bleed rate (ABR) - previously treated patients (PTPs) | Annual bleed rate (ABR) of PTPs on a prophylaxis regimen | Throughout the study participation period: 1 year for previously treated patients (PTPs) | 
| Annual bleed rate (ABR) - previously untreated patients (PUPs) | Annual bleed rate (ABR) of PUPs on a prophylaxis regimen | Throughout the study participation period: 2 years for previously untreated patients (PUPs) | 
| Doses to treat a bleed of participants on an on-demand regimen - previously treated patients (PTPs) | Number of doses to treat a bleed of PTPs on an on-demand regimen | At bleed resolution throughout the study participation period: 1 year for previously treated patients (PTPs) | 
| Doses to treat a bleed of participants on an on-demand regimen - previously untreated patients (PUPs) | Number of doses to treat a bleed of PUPs on an on-demand regimen | At bleed resolution throughout the study participation period: 2 years for previously untreated patients (PUPs). | 
| Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen - previously treated patients (PTPs) | Based on a 4-point ordinal scale (poor, fair, good, excellent) | At bleed resolution throughout the study participation period: 1 year for previously treated patients (PTPs) | 
| Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen - previously untreated patients (PUPs) | Based on a 4-point ordinal scale (poor, fair, good, excellent) | At bleed resolution throughout the study participation period: 2 years for previously untreated patients (PUPs). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants who experience shock or anaphylaxis - previously treated patients (PTPs) | Number of PTPs who experience shock or anaphylaxis | Throughout the study participation period: 1 year for previously treated patients (PTPs) | 
| Participants who experience shock or anaphylaxis - previously untreated patients (PUPs) | Number of PUPs who experience shock or anaphylaxis | Throughout the study participation period: 2 years for previously untreated patients (PUPs) |