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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Hemophilia A

Treatments: Genetic: BDDrFVIII; Genetic: B-Domain deleted Recombinant Factor VIII; Genetic: ReFacto AF

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141843

3082B2-310

Details and patient eligibility

About

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.

Sex: Male

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind