At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
BENEFIXdrug
Likely dose
BENEFIX 50 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Single Dose Pharmacokinetic Study Of Benefix (Nonacog Alfa, Recombinant Factor Ix) In Male Chinese Subjects With Hemophilia B
In Brief
A Phase 1 clinical trial evaluating BENEFIX for Hemophilia B. Completed, enrolled 12 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartMar 2015
Primary CompletionApr 2015
TodayJul 2026
First PostedAug 11, 2014
Enrollment StartMar 1, 2015
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.9 years ago
Interventions
BENEFIXdrug
Single dose of 50 IU/kg of BeneFIX by intravenous infusion within 10 minutes.