Brief Title
Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B
Official Title
A Double-Blind, Randomized, Crossover Evaluation of the Pharmacokinetics of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R); and an Open-Label Safety and Efficacy Evaluation of rFIX-R in Previously Treated Patients With Moderate to Severe (FIX:C≤2%) Hemophilia B
Brief Summary
The primary objective of this clinical research study is to establish the bioequivalence of 2 treatments, rFIX and rFIX-R, when given as a 10-minute intravenous bolus infusion.
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
Completion Date
September 2005
Eligibility Criteria
Inclusion Criteria: - Moderate to severe hemophilia B (FIX: C ≤2%) - Previously treated patients (PTPs) with ≥150 documented exposure days - Age ≥ 12 years (US sites only) Exclusion Criteria: - Detectable factor IX inhibitor defined as ≥0.6 Bethesda Units for pooled plasma reported by the local laboratory (family history of inhibitors will not exclude the patient) - Patient history of factor IX inhibitor replacement therapy - Patient unable to be off factor IX replacement therapy for at least 5 days without bleeding
Gender
All
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, MD, ,
Administrative Informations
NCT ID
NCT00093210
Organization ID
3090A1-304
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
December 2007