A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A
About the study
The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria
- Signed informed consent obtained from participant and/or legally authorised representative before any study related activities (any procedure related to recording of data according to the protocol).
- Participant at any age with haemophilia A prescribed ADYNOVI/ADYNOVATE prophylaxis.
- Negative factor VIII (FVIII) inhibitor test at study entry.
- Decision to initiate treatment with commercially available ADYNOVI/ADYNOVATE has been made by the participant and/or legally authorised representative and the treating physician before and independently from the decision to include the participant in this study.
EXCLUSION CRITERIA
Exclusion Criteria
- Previous participation in this study. Participation is defined as signed informed consent.
- Known or suspected hypersensitivity to ADYNOVI/ADYNOVATE or related products.
- Mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation.
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
200
Est. Completion Date
Feb 28, 2030
Treatment type
Observational
Sponsor
Takeda
ClinicalTrials.gov identifier
NCT04158934
Study number
TAK-660-403
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