Status:
COMPLETED
Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
Lead Sponsor:
Bioverativ Therapeutics Inc.
Conditions:
Hemophilia A
Eligibility:
MALE
Phase:
PHASE3
Brief Summary
The primary objective of the study is to evaluate the long-term safety of recombinant human Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary objective of the s...
Detailed Description
Participant will follow either a prophylaxis or on-demand regimen. The starting dose in this study will be determined by the clinical profile of the participant in the preceding studies A-LONG - 997HA...
Eligibility Criteria
Inclusion
- Key
- Subjects who have completed previous rFVIIIFc studies (NCT01181128, NCT02083965, NCT01458106 and NCT02502149)
- Ability to understand purposes and risks of the study and to provide signed and dated informed consent (or assent, as applicable).
- Key
Exclusion
- Confirmed positive high-titer inhibitor (≥5.00 BU/mL).
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01454739
Start Date
December 1 2011
End Date
October 1 2017
Last Update
December 19 2020
Active Locations (78)
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1
Research Site
Los Angeles, California, United States, 90007
2
Research Site
Los Angeles, California, United States, 90027
3
Research Site
Orange, California, United States, 92868
4
Research Site
Sacramento, California, United States, 95817