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

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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

Trial contacts and locations

41

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Data sourced from clinicaltrials.gov

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