Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study is to investigate the safety, tolerability, and pharmacokinetics (the determination of the concentration of the administered drug in blood over time) of recombinant Factor VIII Fc fusion protein (rFVIIIFc) in previously-treated subjects with severe hemophilia A.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen; Bioverativ Therapeutics Inc.
• Treatments: Factor VIII

Criteria

Inclusion Criteria:

1. Male and 12 years of age and older and weigh at least 40 kg

2. Diagnosed with severe hemophilia A (baseline Factor VIII level less than 1%)

3. History of at least 100 exposure days to any Factor VIII product

Exclusion Criteria:

1. History of Factor VIII inhibitors

2. Kidney or liver dysfunction

3. Diagnosed with another coagulation defect other than hemophilia A