Status:
COMPLETED
Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Hemophilia B
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Moderate to severe hemophilia B (FIX: C ≤2%)
- Previously treated patients (PTPs) with ≥150 documented exposure days
- Age ≥ 12 years (US sites only)
Exclusion
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00093210
End Date
September 1 2005
Last Update
December 5 2007
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