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

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.

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.

Conditions

Hemophilia A

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• 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:

• 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.

Study Start

July 2005

Eligibility & Criteria

• Ages Eligible for Study: 12 Years and above
• Genders Eligible for Study: Male

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

Total Enrolment

100

Contact Details

• PERTH, 6000, Australia

Email: medinfo@wyeth.com, referring to study as NCT00141843