Status:
COMPLETED
Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A
Lead Sponsor:
Bioverativ Therapeutics Inc.
Collaborating Sponsors:
Swedish Orphan Biovitrum
Conditions:
Severe Hemophilia A
Eligibility:
MALE
12+ years
Phase:
PHASE3
Brief Summary
The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; ...
Detailed Description
Participants are assigned to one of three treatment regimens: 1) a tailored prophylaxis regimen, 2) a weekly dosing regimen, or 3) an on-demand regimen. Treatment continued for 28 (±2) to 52 (±2) week...
Eligibility Criteria
Inclusion
- Male, ≥12 years of age with weight at least 40 kg
- Diagnosed with severe hemophilia A, defined as \<1 IU/dL (\<1%) endogenous Factor VIII)
- History of at least 150 documented prior exposure days to any Factor VIII product
- Platelet count ≥100,000 cells/μL
Exclusion
- History of Factor VIII inhibitors
- Kidney and liver dysfunction
- Diagnosed with other coagulation disorder(s) in addition to hemophilia A
- Prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT01181128
Start Date
November 1 2010
End Date
August 1 2012
Last Update
January 8 2021
Active Locations (64)
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1
Research Site
Little Rock, Arkansas, United States
2
Research Site
Los Angeles, California, United States
3
Research Site
Orange, California, United States
4
Research Site
Sacramento, California, United States