Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B

Phase 3

Completed

• Conditions: Hemophilia B

• Registration Number: NCT00093210
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-10-04
• Study First Submitted QC: 2004-10-06
• Study First Posted: 2004-10-07
• Study Completion: 2005-09
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-03
• Last Update Posted: 2007-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER