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Study Comparing On-Demand Treatment With Two Prophylaxis Regimens Of BeneFIX In Patients With Severe Hemophilia B

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85016 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia B
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00364182
Pfizer
Completed
Study Comparing On-Demand Treatment With Two Prophylaxis Regimens Of BeneFIX In Patients With Severe Hemophilia B

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[email protected]

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