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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hemophilia B

Treatments: Drug: BENEFIX

Study type: Interventional

Funder types: Industry

Identifiers

NCT02213250

2015-003027-61 (EudraCT Number)

B1821048

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

• 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

BeneFIX

Experimental group

Treatment:

Drug: BENEFIX