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Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects

Last updated on March 15, 2019

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Study Location
Pfizer Investigational Site
Guangzhou, Guangzhou, 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
6 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia B
(FIX activity: more than 5%, 1-5%, or less than 1%, respectively)

- Subjects with previous exposure to FIX replacement therapy

- If HIV positive, documented CD4 count more than 200/µL within 6 months of study entry

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Diagnosed with any bleeding disorder in addition to hemophilia B

- Current FIX inhibitor or history of FIX inhibitor (defined as >ULN of the reporting
laboratory)

- Subject has no history of exposure to FIX products (previously untreated patient
[PUP])

- Subject is currently utilizing primary FIX prophylaxis

- Subjects anticipating elective surgery that may be planned to occur in the 6 months
following study entry

- Treated with immunomodulatory therapy within 30 days prior to study entry or planned
use for the duration of their study participation

- Participated in another investigational drug or device study within 30 days prior to
study entry or planned participation for the duration of their study participation

- Subjects with a known hypersensitivity to hamster protein

- Significant hepatic or renal impairment (ALT and AST >5 x ULN, bilirubin >2 mg/dL or
serum creatinine >1.25 x ULN)

- Prothrombin Time >1.5 x ULN

- Platelet count

- Pregnant or breastfeeding women

- Unwilling or unable to follow the terms of the protocol

- Any condition which may compromise the subject's ability to comply with and/or perform
study-related activities or that poses a clinical contraindication to study
participation, in the opinion of the Investigator or Sponsor

NCT00866606
Pfizer
Completed
Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects

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