Status:
COMPLETED
An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A
Lead Sponsor:
Bioverativ, a Sanofi company
Collaborating Sponsors:
Swedish Orphan Biovitrum
Conditions:
Hemophilia A
Eligibility:
MALE
Up to 5 years
Phase:
PHASE3
Brief Summary
The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the ...
Eligibility Criteria
Inclusion
- Key
- Ability of the participant's legally authorized representative (e.g. their parent or legal guardian) to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations.
- Weight \>=3.5 kg at the time of screening.
- Severe hemophilia A defined as less than (\<) 1 IU/dL (\<1%) endogenous FVIII documented in the medical record or as tested during the Screening Period.
- Key
Exclusion
- Any exposure to blood components, factor VIII replacement products, including commercially available rFVIIIFc at any time prior to or during screening.
- History of positive inhibitor testing. A prior history of inhibitors was defined based on a patient's historical positive inhibitor test using the local laboratory Bethesda value for a positive inhibitor test (ie, equal to or above lower level of detection).
- History of hypersensitivity reactions associated with any rFVIIIFc administration.
- Other coagulation disorder(s) in addition to hemophilia A.
- Any concurrent clinically significant major disease that, in the opinion of the Investigator, would make the participant unsuitable for enrollment.
- Current systemic treatment with chemotherapy and/or other immunosuppressant drugs.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
January 12 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2019
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT02234323
Start Date
January 12 2015
End Date
September 23 2019
Last Update
April 11 2022
Active Locations (71)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Little Rock, Arkansas, United States, 72202
2
Research Site
Duarte, California, United States, 91010
3
Research Site
Sacramento, California, United States, 95817
4
Research Site
San Francisco, California, United States, 94143