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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00141843
First received: August 30, 2005
Last updated: April 21, 2008
Last verified: April 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Hemophilia A
 Genetic: ReFacto AF
Genetic: B-Domain deleted Recombinant Factor VIII
Genetic: BDDrFVIII
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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.

Resource links provided by NLM:

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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.

Estimated Enrollment: 100
Study Start Date: July 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141843

  Show 41 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, MedInfoDEU@wyeth.com
Principal Investigator: Trial Manager For Italy, descresg@wyeth.com
Principal Investigator: Trial Manager For Australia, New Zealand, medinfo@wyeth.com
Principal Investigator: Trial Manager For Netherlands, trials-NL@wyeth.com
Principal Investigator: Trial Manager For Sweden, Finland,MedInfoNord@wyeth.com
Principal Investigator: Trial Manager For Hungary, WPBUMED@wyeth.com
Principal Investigator: Trial Manager For Poland, WVWZMED@wyeth.com
Principal Investigator: Trial Manager For Belgium, trials-BEL@wyeth.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00141843     History of Changes
Other Study ID Numbers: 3082B2-310
Study First Received: August 30, 2005
Last Updated: April 21, 2008
Health Authority: United States: Food and Drug Administration
Belgium: Institutional Review Board
France: Ministry of Health
Germany: Ethics Commission
Italy: Ministry of Health
Mali: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Greece: National Organization of Medicines
Turkey: Ministry of Health
Spain: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health
Switzerland: Swissmedic
Israel: Israeli Health Ministry Pharmaceutical Administration
Hungary: National Institute of Pharmacy
Croatia: Ministry of Health and Social Care
Poland: Ministry of Health
Czech Republic: State Institute for Drug Control
United Kingdom: National Health Service
Australia: Human Research Ethics Committee
New Zealand: Health Research Council
Taiwan: Department of Health

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Hemophilia A

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
 Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013