Study Evaluating rFIX; BeneFIX® in Hemophilia B

Phase 3

Completed

• Conditions: Hemophilia B

• Registration Number: NCT00093171
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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).

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
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-20
• Last Update Posted: 2009-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified