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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Hemophilia B

Treatments: Drug: rFIX; Drug: rFIX-R

Study type: Interventional

Funder types: Industry

Identifiers

NCT00093210

3090A1-304

Details and patient eligibility

About

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.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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