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

Completed · Phase 3

Conditions studied: Severe Hemophilia A

In brief

The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical treatment regimen. The secondary objectives of this study are: to characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.

Key facts

Study ID

NCT01181128

Run by

Bioverativ Therapeutics Inc.

People needed

165

Starts

2010-11-01

Expected to finish

2012-08-01

Last updated by the study team

2021-01-08

Who can join

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

You may qualify if…

• Male, ≥12 years of age with weight at least 40 kg
• Diagnosed with severe hemophilia A, defined as <1 IU/dL (<1%) endogenous Factor VIII)
• History of at least 150 documented prior exposure days to any Factor VIII product
• Platelet count ≥100,000 cells/μL

You may not qualify if…

• History of Factor VIII inhibitors
• Kidney and liver dysfunction
• Diagnosed with other coagulation disorder(s) in addition to hemophilia A
• Prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — Orange, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Diego, California, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Iowa City, Iowa, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — East Lansing, Michigan, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — New York, New York, United States
• Research Site — Chapel Hill, North Carolina, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Houston, Texas, United States
• Research Site — Salt Lake City, Utah, United States
• Research Site — Seattle, Washington, United States
• Research Site — Camperdown, New South Wales, Australia
• Research Site — Adelaide, South Australia, Australia
• Research Site — Perth, Western Australia, Australia
• Research Site — Vienna, Austria
• Research Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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