Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective of the study is to evaluate the effectiveness of prophylactic treatment with recombinant Factor VIII Fc fusion protein (rFVIIIFc) and recombinant Factor IX Fc fusion protein (rFIXFc) therapy as assessed by patient treatment burden and health economic outcomes while maintaining disease control in males with hemophilia A or B.

• Accepts Healthy Volunteers?: No

Details

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

Criteria

Key Inclusion Criteria:

• Have a medically documented diagnosis of hemophilia A or B that is being treated prophylactically with a factor replacement product not designed to have a prolonged half-life and satisfy a therapeutic indication for rFVIIIFc/rFIXFc per the approved local label

• Have at least 50 prior exposure days (EDs) to any combination of factor replacement products

• Have documented pre-study data available that confirm fulfillment of the eligibility criteria

• Have no measurable inhibitor activity in a sample obtained within 4 weeks prior to the Baseline visit, and absence of clinical signs or symptoms of decreased response to the current factor replacement product

Key Exclusion Criteria:

• Have a diagnosis of any bleeding disorder other than hemophilia A or hemophilia B or an additional coagulation disorder(s) in addition to hemophilia A or hemophilia B

• Have a prior history of anaphylaxis associated with any factor VIII (FVIII)/ factor IX (FIX) or intravenous immunoglobin administration

• Had an inhibitor within 5 years before the Baseline visit. Note: A family history of inhibitors will not exclude the patient.

• Past or current treatment with any factor replacement product with a prolonged half-life, including an Fc product, for the treatment of hemophilia

NOTE: Other Protocol Defined Inclusion/ Exclusion Criteria May Apply.