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Study Evaluating ReFacto AF in Severe Hemophilia A

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ClinicalTrials.gov Identifier: NCT00037544
Recruitment Status : Completed
First Posted : May 20, 2002
Last Update Posted : April 22, 2008
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.

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

Study Type : Interventional  (Clinical Trial)
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
Primary Completion Date : August 2004
Study Completion Date : August 2004






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
Criteria

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

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): NCT00037544


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier: NCT00037544     History of Changes
Other Study ID Numbers: 3082B1-306
First Posted: May 20, 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:
Severe
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