Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B
Status: | Completed |
---|---|
Conditions: | Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 12 - 65 |
Updated: | 3/30/2013 |
Start Date: | September 2011 |
End Date: | May 2014 |
Contact: | Pfizer CT.gov Call Center |
Phone: | 1-800-718-1021 |
A Multicenter, Open-Label Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of Nonacog-Alfa (BeneFIX) In Subjects With Moderately Severe To Severe Hemophilia B (FIX:C=2%)
The purpose of this study will be to determine if a once-weekly prophylaxis regimen of
BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.
Inclusion Criteria:
- Documented history of moderately-severe to severe hemophilia B (FIX activity =2%).
- Male subjects, aged 12 years to 65 years.
- Subjects with at least 100 exposure days (EDs) to factor IX products.
- Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in
the 12-month period before the Screening visit.
Exclusion Criteria:
- Subjects who have received FIX as a primary or secondary prophylaxis regimen within
the last 12 months prior to the Screening visit.
- Subjects who have had major surgery or an orthopedic surgical procedure within the
past 3 months prior to Screening visit.
- Subjects for which major surgery or orthopedic surgery is planned within the duration
of study participation.
- Subjects with a past history of, or current FIX inhibitor, defined as >ULN (upper
limit of normal) of the reporting laboratory.
- Subjects with a known hypersensitivity to any FIX product or hamster protein.
We found this trial at
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The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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