At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 35 enrolled
Drug / intervention
Benefixbiological
Likely dose
Benefix 75 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 Evaluation Of The Safety And Efficacy Of On-Demand Treatment With BeneFIX (Nonacog Alfa, Recombinant Factor IX) In Chinese Subjects With Hemophilia B
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Mar 20, 2009·Updated Apr 5, 2011
In Brief
A Phase 3 clinical trial evaluating Benefix for Hemophilia B. Completed, enrolled 35 participants across 6 sites.
Detailed Summary
This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedMar 2009
Primary CompletionDec 2009
TodayJul 2026
First PostedMar 20, 2009
Enrollment StartFeb 1, 2009
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.3 years ago
Interventions
Benefixbiological
BeneFIX for on-demand treatment of bleeding episodes were according to investigator prescription. FIX recovery was assessed by determining the FIX activity (FIX:C) levels in individual subjects. BeneFIX dosage for recovery assessments: single 75 IU/kg (±5 IU/kg) IV bolus infusion.