At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 70 enrolled
Drug / intervention
Benefixdrug
Likely dose
Not stated in 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-arm, Post-authorization Pragmatic Clinical Trial On The Safety And Efficacy Of Benefix (Nonacog Alfa, Recombinant Factor Ix) In Subjects With Hemophilia B In Usual Care Settings In China
In Brief
A Phase 4 clinical trial evaluating Benefix for HEMOPHILIA B. Completed, enrolled 70 participants across 16 sites.
Detailed Summary
The purpose of this post-approval study is to evaluate the safety and efficacy of Benefix in subjects with hemophilia B in usual care settings in China.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHEMOPHILIA B
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJan 2015
First PostedJan 2015
Primary CompletionJul 2016
Study CompletionAug 2016
TodayJul 2026
First PostedJan 12, 2015
Enrollment StartJan 1, 2015
Primary CompletionJul 1, 2016
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.5 years ago
Interventions
Benefixdrug
Subjects will be treated by the investigator according to usual care in China and in accord with the China BeneFIX Package Insert. The treatment duration is approximately 6 months (±7 days) or approximately 50 Exposure Days (EDs) (±5 EDs) (see protocol definition on EDs) whichever occurs first.