Study Evaluating rFIX; BeneFIX® in Hemophilia B

This study is ongoing, but not recruiting participants.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00093171

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 III

Genetics Home Reference related topics: hemophilia L1 syndrome

Drug Information available for: Factor IX

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Safety/Efficacy Study
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%)

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

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

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

Study ID Numbers:	3090A1-302
Study First Received:	October 4, 2004
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00093171
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hemophilia B
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases

Blood Coagulation Disorders
Hemophilia A
Genetic Diseases, X-Linked
Hemostatic Disorders

Additional relevant MeSH terms:

Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders

ClinicalTrials.gov processed this record on January 14, 2009