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

Wyeth is now a wholly owned subsidiary of Pfizer0 sitesOctober 7, 2004

ConditionsHemophilia B

DrugsrFIX rFIX-R

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hemophilia B
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 7, 2004

End Date

September 2005

Last Updated

18 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

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