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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Two-Way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII,Refacto AF) With a Full Length R

Brief Summary: 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.

Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Current Primary Outcome: To determine the incidence rate of Factor VIII inhibitors in the study patient population.To establish bioequivalence of ReFacto AF as compared to Advate using the one stage Factor VIII activity assay.

Original Primary Outcome: Same as current

Current Secondary Outcome: To characterize the efficacy of ReFActo AF in preventing and treating bleeding episodes during prophylaxis.To characterize PK of ReFacto AF as compared to Advate over time.

Original Secondary Outcome: Same as current

Information By: Wyeth is now a wholly owned subsidiary of Pfizer

Dates:
Date Received: August 30, 2005
Date Started: July 2005
Date Completion:
Last Updated: April 21, 2008
Last Verified: April 2008