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Study Evaluating rFIX; BeneFIX® in Hemophilia B

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00093171
First received: October 4, 2004
Last updated: August 20, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Hemophilia B
Drug: rFIX
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: 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%)

Resource links provided by NLM:


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

Enrollment: 23
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093171

Locations
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
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00093171     History of Changes
Other Study ID Numbers: 3090A1-302
Study First Received: October 4, 2004
Last Updated: August 20, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014