Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A

Completed · Phase 3

Conditions studied: Hemophilia A

In brief

The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.

Key facts

Study ID

NCT00141843

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

100

Starts

2005-07-01

Expected to finish

2006-11-01

Last updated by the study team

2008-04-22

Who can join

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

You may qualify if…

• Male subjects with severe or moderately severe hemophilia A
• A negative past medical history of a Factor VIII inhibitor
• Age greater than or equal to 12 years

You may not qualify if…

• A history of Factor VIII inhibitors
• Presence of a bleeding disorder in addition to hemophilia
• Known hypersensitivity to hamster protein

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Atlanta, Georgia, United States
• Study site — Iowa City, Iowa, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Worcester, Massachusetts, United States
• Study site — East Lansing, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — New Hyde Park, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Dayton, Ohio, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Perth, Australia
• Study site — Leuven, Belgium
• Study site — Helsinki, Finland
• Study site — Le Kremlin-Bicêtre, France

Full record on ClinicalTrials.gov

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