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Safety and Efficacy of Benefix in Patients With Hemophilia B in Usual Care Settings in China

Last updated on March 14, 2019

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Study Location
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515 China
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
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male and/or female subjects with hemophilia B.

- Subjects/parents/legal representatives must be able to comply with study procedures
(informed consent/assent process, clinical visits, reporting of infusion and bleed
data, reporting of adverse events, etc)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Presence of any other bleeding disorder in addition to hemophilia B. Subjects with a
past history of, or current factor IX inhibitor. For laboratory-based assessments, any
Bethesda inhibitor titer greater than the laboratory's normal range or ?0.6 Bethesda
Unit (BU)/mL.

- Subjects with known hypersensitivity to the active substance or to any of the
excipients of BeneFIX.

- Subjects with a known hypersensitivity to Chinese Hamster Ovary cell proteins.

NCT02336178
Pfizer
Completed
Safety and Efficacy of Benefix in Patients With Hemophilia B in Usual Care Settings in China

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