Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
Phase 3
Completed
- Conditions
- Hemophilia A
- Registration Number
- NCT00141843
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 100
Inclusion Criteria
- 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
Exclusion Criteria
- A history of Factor VIII inhibitors
- Presence of a bleeding disorder in addition to hemophilia
- Known hypersensitivity to hamster protein
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.