Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

Criteria

Key Inclusion Criteria:

• Severe hemophilia B defined as ≤ 2 IU/dl (≤ 2%) endogenous FIX

• Male < 12 years and weight ≥ 13 kg

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

• No history of, or currently detectable, inhibitor

Key Exclusion Criteria:

• Other coagulation disorders in addition to Hemophilia B

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

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