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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc consumption for prevention and treatment of bleeding episodes.

• 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

Key Inclusion Criteria:

• Severe hemophilia A defined as <1 IU/dL (<1%) endogenous FVIII

• Male <12 years of age and weight ≥13 kg

• History of at least 50 documented prior exposure days to FVIII

• No current, or history of, inhibitor development to FVIII

Key Exclusion Criteria:

• Other coagulation disorders in addition to Hemophilia A

• History of anaphylaxis associated with any FVIII or IV immunoglobulin administration

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.