Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Male

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; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical treatment regimen. The secondary objectives of this study are: to characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen; Bioverativ Therapeutics Inc.
• Collaborator: Swedish Orphan Biovitrum
• Treatments: Factor VIII; Immunoglobulin Fc Fragments

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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