Brief Title
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
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 Recombinant Factor VIII Preparation (FLrFVIII,Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients With Hemophilia A.
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.
Study Phase
Phase 3
Study Type
Interventional
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.
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.
Condition
Hemophilia A
Intervention
ReFacto AF
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Genetic
Estimated Enrollment
100
Start Date
July 2005
Completion Date
November 2006
Primary Completion Date
November 2006
Eligibility Criteria
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
Gender
Male
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00141843
Organization ID
3082B2-310
Study Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor
Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date
April 2008