Brief Title
A Post Marketing Surveillance Study for ADYNOVATE in South Korea
Official Title
A Post Marketing Surveillance Study for ADYNOVATE in South Korea
Brief Summary
The purpose of this study is to characterize the safety and describe hemostatic effectiveness in patients receiving ADYNOVATE in routine clinical practice.
Study Type
Observational
Primary Outcome
Incidence of adverse events
Secondary Outcome
Incidence of inhibitor titers for FVIII antibodies
Condition
Hemophilia A
Intervention
ADYNOVATE
Study Arms / Comparison Groups
All Study Participants
Description: All participants enrolled will be treated with ADYNOVATE for hemophilia A at the time of enrollment according to a regimen determined by the study site treating physician/investigator.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
600
Start Date
February 25, 2019
Completion Date
December 31, 2023
Primary Completion Date
December 31, 2023
Eligibility Criteria
Inclusion Criteria Participants with a diagnosis of hemophilia A who have been prescribed ADYNOVATE according to the investigator'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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Study Director, +1 866 842 5335, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT03824522
Organization ID
261603
Responsible Party
Sponsor
Study Sponsor
Shire
Study Sponsor
Study Director, Study Director, Takeda
Verification Date
December 2021