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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BeneFIX

Group Type EXPERIMENTAL

BENEFIX

Intervention Type DRUG

Single dose of 50 IU/kg of BeneFIX by intravenous infusion within 10 minutes.

Interventions

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BENEFIX

Single dose of 50 IU/kg of BeneFIX by intravenous infusion within 10 minutes.

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

6 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No