Study Evaluating rFIX; BeneFIX® in Hemophilia B

Completed · Phase 3

Conditions studied: Hemophilia B

In brief

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).

Key facts

Study ID

NCT00093171

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

23

Expected to finish

2005-05-01

Last updated by the study team

2009-08-21

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Detroit, Michigan, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Dayton, Ohio, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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