Status:
COMPLETED
Post Marketing Surveillance Study for ADYNOVATE in South Korea
Lead Sponsor:
Takeda
Collaborating Sponsors:
Takeda Pharma Korea Co. Ltd.
Conditions:
Hemophilia A
Eligibility:
All Genders
Brief Summary
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 ef...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 5 2024
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT03824522
Start Date
February 25 2019
End Date
January 5 2024
Last Update
February 26 2024
Active Locations (8)
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1
Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404
2
Kyungpook National University Hospital
Daegu, South Korea, 41944
3
Daegu Catholic University Medical Center
Daegu, South Korea, 42472
4
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722