Status:
COMPLETED
A Study in Children, Teenagers and Adults With Severe Hemophilia A Who Switched From Other Factor VIII Treatments to Adynovate
Lead Sponsor:
Takeda
Conditions:
Hemophilia A
Eligibility:
All Genders
Brief Summary
The main aims of the study are to assess the safety profile of Adynovate as well as how well people respond to the preventive treatment with Adynovate. This study is about reviewing and collecting da...
Eligibility Criteria
Inclusion
- Participants with severe hemophilia A.
- All age groups (less than \[\<\] 12 and greater than \[\>\] 12 years of age).
- Participant with greater than equal to (\>=) 150 documented exposure days (EDs).
- Treated with Adynovate:
- Having a PK analysis done/data available for post-hoc modeling
- Having recorded clinical outcomes analysis: for \> 6 months
- Treated with a SHL/EHL-FVIII product for at least six months before switching to Adynovate
- To qualify for the secondary objective participants will need to have a WAPPS study performed on Adynovate and on the SHL/EHL-FVIII they were treated before switching.
Exclusion
- Any participant who meets any of the following criteria will not qualify for entry into the study:
- Participants with only on-demand Factor VIII (FVIII) use.
- Current presence of FVIII inhibitory antibodies. (Participants with a history of inhibitors, if any, will be considered for a sensitivity analysis).
- Diagnosis of other inherited or acquired hemostatic defect other than hemophilia A.
Key Trial Info
Start Date :
November 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04876365
Start Date
November 30 2021
End Date
February 28 2022
Last Update
July 24 2023
Active Locations (1)
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1
Hamilton-Niagara Regional Hemophilia Treatment Centre
Hamilton, Ontario, Canada, L8N 3Z5