An Open-label Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX®) in Previously Treated Patients (PTPs) With Hemophilia B (FIX:C ≤2%)

Wyeth is now a wholly owned subsidiary of Pfizer0 sites23 target enrollmentOctober 7, 2004

ConditionsHemophilia B

DrugsrFIX

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hemophilia B
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 23
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).

Registry

clinicaltrials.gov

Start Date

October 7, 2004

End Date

May 2005

Last Updated

16 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

Inclusion Criteria

•Hemophilia B (FIX:C less than 2%)
•Previous treatment of at least 150 exposure days using any FIX product
•12 years of age and older

Exclusion Criteria

•The patient has a currently detectable factor IX inhibitor or a history of inhibitors. (A family history of inhibitors will not exclude the patient)
•Known hypersensitivity to protein pharmaceuticals or agents related to the test article, e.g. hamster proteins
•Patient has a genetic coagulation disorder other than hemophilia B