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An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B

Last updated on March 14, 2019

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Study Location
Peking Union Medical College Hospital
Beijing, , 100032 China
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 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male Chinese subjects 6 years or older (weight ≥20kg) with moderate to severe
hemophilia B (Factor IX activity ≤2%).

- Subjects should not have received an infusion of any Factor IX products for at least 4
days before the administration of BeneFIX on Day 1.

- Subjects must be in a non-bleeding state before the administration of BeneFIX on Day
1.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing) disease or clinical findings at Screening.

- Diagnosed with any other bleeding disorder in addition to hemophilia B.

- Current FIX inhibitor or history of FIX inhibitor (defined as > Upper Limit of Normal
(ULN) of the reporting lab).

NCT02213250
Pfizer
Completed
An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B

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