Post Marketing Surveillance Study for ADYNOVATE in South Korea
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Hemophilia A
Participants needed
600
Est. Completion Date
Jan 30, 2024
Treatment type
Observational
Sponsor
Takeda
ClinicalTrials.gov identifier
NCT03824522
Study number
261603
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