Status:
COMPLETED
Study Evaluating rFIX; BeneFIX® in Hemophilia B
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Hemophilia B
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00093171
End Date
May 1 2005
Last Update
August 21 2009
Active Locations (7)
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1
Los Angeles, California, United States, 90027
2
Aurora, Colorado, United States, 80262
3
Detroit, Michigan, United States, 48201
4
New Brunswick, New Jersey, United States, 08903