Study Evaluating rFIX; BeneFIX® in Hemophilia B

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

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