Brief Title
Study Evaluating rFIX; BeneFIX® in Hemophilia B
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%)
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).
Study Phase
Phase 3
Study Type
Interventional
Condition
Hemophilia B
Intervention
rFIX
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
23
Completion Date
May 2005
Primary Completion Date
May 2005
Eligibility 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
Gender
All
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00093171
Organization ID
3090A1-302
Study Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor
Medical Monitor, MD, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date
August 2009