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Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

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ClinicalTrials.gov Identifier: NCT00038935
Recruitment Status : Completed
First Posted : June 7, 2002
Last Update Posted : April 22, 2008
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine the relative bioavailability of ReFacto AF as compared to ReFacto, when each is administered as 2-minute bolus infusions.

Condition or disease Intervention/treatment Phase
Hemophilia A Drug: ReFacto AF Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Single Dose, Randomized, Double-Blind, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of B-Domain Deleted Recombinant Human Factor VIII (BDDrFVIII) Manufactured by the Current Process (ReFacto) and by an Albumin Free Manufacturing Process (ReFacto AF)
Primary Completion Date : February 2003
Study Completion Date : February 2003

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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 < 1% at local laboratory)
  • Previously treated patients (PTP) with at least 250 exposure days to any factor VIII product
  • Age greater than or equal to 12 years\

Exclusion Criteria:

  • The presence of any bleeding disorder in addition to hemophilia A
  • Concomitant therapy with immunosuppressant drugs (e.g., intravenous immunoglobulin (IVIG), routine systemic corticosteroid use)
  • History of detectable factor VIII inhibitor
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038935

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

ClinicalTrials.gov Identifier: NCT00038935     History of Changes
Other Study ID Numbers: 3082B1-305
First Posted: June 7, 2002    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 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