Study Evaluating rFIX; BeneFIX® in Hemophilia B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00093171
Recruitment Status : Completed
First Posted : October 7, 2004
Last Update Posted : August 21, 2009
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).

Condition or disease Intervention/treatment Phase
Hemophilia B Drug: rFIX Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX®) in Previously Treated Patients (PTPs) With Hemophilia B (FIX:C ≤2%)
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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:

  • Hemophilia B (FIX:C less than 2%)
  • Previous treatment of at least 150 exposure days using any FIX product
  • 12 years of age and older

Exclusion Criteria:

  • The patient has a currently detectable factor IX inhibitor or a history of inhibitors. (A family history of inhibitors will not exclude the patient)
  • Known hypersensitivity to protein pharmaceuticals or agents related to the test article, e.g. hamster proteins
  • Patient has a genetic coagulation disorder other than hemophilia B

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 identifier (NCT number): NCT00093171

United States, California
Los Angeles, California, United States, 90027
United States, Colorado
Aurora, Colorado, United States, 80262
United States, Michigan
Detroit, Michigan, United States, 48201
United States, New Jersey
New Brunswick, New Jersey, United States, 08903
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599-7016
United States, Ohio
Dayton, Ohio, United States, 45404
United States, Texas
Houston, Texas, United States, 77030
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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00093171     History of Changes
Other Study ID Numbers: 3090A1-302
First Posted: October 7, 2004    Key Record Dates
Last Update Posted: August 21, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked