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

Completed · Phase 1

Conditions studied: Severe Hemophilia A

In brief

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.

Key facts

Study ID

NCT01027377

Run by

Bioverativ Therapeutics Inc.

People needed

16

Starts

2009-12-01

Expected to finish

2011-05-01

Last updated by the study team

2020-12-19

Who can join

Age: 12 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male and 12 years of age and older and weigh at least 40 kg
• Diagnosed with severe hemophilia A (baseline Factor VIII level less than 1%)
• History of at least 100 exposure days to any Factor VIII product

You may not qualify if…

• History of Factor VIII inhibitors
• Kidney or liver dysfunction
• Diagnosed with another coagulation defect other than hemophilia A

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — Sacramento, California, United States
• Research Site — Waltham, Massachusetts, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Seattle, Washington, United States
• Research Site — Hong Kong, Hong Kong
• Research Site — Tel Aviv, Israel

Full record on ClinicalTrials.gov

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