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Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B

Last updated on March 14, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia B
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Moderate to severe hemophilia B (FIX: C ≤2%)

- Previously treated patients (PTPs) with ≥150 documented exposure days

- Age ≥ 12 years (US sites only)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Detectable factor IX inhibitor defined as ?0.6 Bethesda Units for pooled plasma
reported by the local laboratory (family history of inhibitors will not exclude the
patient)

- Patient history of factor IX inhibitor replacement therapy

- Patient unable to be off factor IX replacement therapy for at least 5 days without
bleeding

NCT00093210
Pfizer
Completed
Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B

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