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Study Evaluating ReFacto AF in Severe Hemophilia A

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: May 17, 2002
Last updated: April 18, 2008
Last verified: April 2008
To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.

Condition Intervention Phase
Hemophilia A
Drug: ReFacto AF
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: An Open-Label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients (PTP) With Severe Hemophilia A

Resource links provided by NLM:

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

Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)
  • Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product
  • Age greater than or equal to 12 years
  • History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study
  • Adequate laboratory results

Exclusion Criteria:

  • Presence of any bleeding disorder in addition to hemophilia A
  • Concomitant therapy with immunosuppressive drugs
  • Current or historical Factor VIII inhibitor
  • Treatment with any investigational drug or device within the past 30 days
  Contacts and Locations
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Please refer to this study by its identifier: NCT00037544

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information Identifier: NCT00037544     History of Changes
Other Study ID Numbers: 3082B1-306
Study First Received: May 17, 2002
Last Updated: April 18, 2008

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

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 processed this record on May 25, 2017