Status:
COMPLETED
An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B
Lead Sponsor:
Pfizer
Conditions:
Hemophilia B
Eligibility:
MALE
6+ years
Phase:
PHASE1
Brief Summary
The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK study and to support the registration in China.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02213250
Start Date
March 1 2015
End Date
April 1 2015
Last Update
July 25 2016
Active Locations (2)
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1
Peking Union Medical College Hospital
Beijing, China, 100032
2
Hematology Department,Beijing Children's Hospital, Capital Medical University
Beijing, China, 100045