Post Marketing Surveillance Study for ADYNOVATE in South Korea

Study Overview
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Brief Summary
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The main aim of this study is to check for side effects and medical problems in participants with hemophilia A who are receiving ADYNOVATE in routine clinical practice. Also, it will be checked how effective ADYNOVATE is at stopping a bleed, at preventing bleeding episodes when used routinely for prevention and at controlling hemophilia-related bleeding during surgeries. Participants with hemophilia A who will be newly prescribed with ADYNOVATE treatment or have already been taking ADYNOVATE treatment according to the physician's decision will be included in this study. Participants will visit the study clinic as a part of their routine clinical practice and will be contacted by phone calls/home visits by home care workers for collection of treatment related data during the 6-month observation period.

Official Title
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Post Marketing Surveillance Study for ADYNOVATE in South Korea

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 Participants with a diagnosis of hemophilia A who will be newly prescribed with ADYNOVATE or already have been prescribed ADYNOVATE according to the study physician's judgment shall be included in this study if: The participant or legally authorized representative has given written informed consent to participate in the study. The participant is indicated for treatment according to the ADYNOVATE South Korea prescribing information (PI). Exclusion Criteria Participants should be excluded from this study if: The participant or legally authorized representative does not wish to participate in the study. Any of the contraindications included in the PI for ADYNOVATE apply. Participant is enrolled in an interventional trial using an investigational product other than 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 |
| --- | --- |
| All Study Participants<br>Participants who are newly prescribed with Adynovate and participants previously treated with Adynovate will be treated with ADYNOVATE for hemophilia A at the time of enrollment according to a regimen determined by the study site treating physician. | Biological: ADYNOVATE<br>* Pegylated recombinant human factor VIII<br>* Other names: PEGylated rFVIII;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Serious adverse events and non-serious adverse events | Throughout the duration of patient participation of up to approximately 6 months | 
| Frequency of adverse events | Serious adverse events and non-serious adverse events | Throughout the duration of patient participation of up to approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of inhibitor titers for FVIII antibodies | By titer levels, high and lower titer categories | Throughout the duration of patient participation of up to approximately 6 months | 
| Number of treated bleeds | Number of treated bleeds throughout the study period | Throughout the duration of patient participation of up to approximately 6 months | 
| ADYNOVATE units required for bleed resolution | Number of ADYNOVATE units required for bleed resolution | At bleed resolution, throughout the duration of patient participation of up to approximately 6 months | 
| Number of ADYNOVATE infusions needed for the treatment of bleeding episodes | The number of ADYNOVATE infusions needed for each bleeding episode is determined by the participant, his/her caregiver, and/or clinician treating the participant, and is based upon the participant's response to treatment | At bleed resolution, throughout the duration of patient participation of up to approximately 6 months | 
| Hemostatic effectiveness assessment of bleeding episodes treated with ADYNOVATE during prophylaxis treatment | Using a 4-point ordinal scale (Excellent, Good, Fair, or None) | Throughout the duration of patient participation of up to approximately 6 months | 
| Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen | Using a 4-point ordinal scale (Excellent, Good, Fair, or None) | At bleed resolution, throughout the duration of patient participation of up to approximately 6 months | 
| Assessment of perioperative effectiveness of ADYNOVATE | Using a 4-point ordinal scale (Excellent, Good, Fair, or None) | Throughout the duration of patient participation of up to approximately 6 months | 
| Clinically significant changes in laboratory results | Number of clinically significant changes in laboratory results | Throughout the duration of patient participation of up to approximately 6 months |