Status:
COMPLETED
Study Comparing On-Demand Treatment With Two Prophylaxis Regimens Of BeneFIX In Patients With Severe Hemophilia B
Lead Sponsor:
Pfizer
Conditions:
Hemophilia B
Eligibility:
MALE
6-65 years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate BeneFIX infused as prophylaxis regimens, compared with BeneFIX administered as an on-demand regimen only. In the trial, subjects will participate in 4 study periods....
Eligibility Criteria
Inclusion
- Documented history of moderately severe or severe hemophilia B (FIX:C less than or equal to 2%)
- Male subjects, aged 6 years to 65 years.
- Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12 months before screening.
Exclusion
- Subjects currently utilizing FIX primary prophylaxis.
- Subjects with HIV+ who have a CD4 count less than 200
- Subjects with hepatic or renal impairment.
- Prothrombin time or International Normalized Ration more than 1.5 times the upper limit of normal.
- Major surgery or an orthopedic surgical procedure within the past 3 months or is planned within the duration of participation in this study.
- Past history of, or current FIX inhibitor.
- Hypersensitivity to any FIX product or hamster protein.
- Exposure to any investigational drug, except for rFIX-R, or device within 30 days of providing consent/assent (as appropriate) for this study.
- Bleeding disorders other than hemophilia B.
- Concurrent inflammatory disease that in the investigator's judgment could confound the study results.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00364182
Start Date
May 1 2007
End Date
October 1 2010
Last Update
October 4 2011
Active Locations (19)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85016
2
Pfizer Investigational Site
Chicago, Illinois, United States, 60612-3833
3
Pfizer Investigational Site
Chicago, Illinois, United States, 60614
4
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08903-0019