Status:
COMPLETED
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Hemophilia A
Eligibility:
MALE
12+ years
Phase:
PHASE3
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 compar...
Eligibility Criteria
Inclusion
- 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
- A history of Factor VIII inhibitors
- Presence of a bleeding disorder in addition to hemophilia
- Known hypersensitivity to hamster protein
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00141843
Start Date
July 1 2005
End Date
November 1 2006
Last Update
April 22 2008
Active Locations (41)
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1
Phoenix, Arizona, United States, 85016
2
Sacramento, California, United States, 95817
3
San Diego, California, United States, 92123
4
Aurora, Colorado, United States, 80045