At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 25 enrolled
Drug / intervention
Nonacog alfa +1 morebiological
Likely dose
Nonacog alfa 100 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.
A Multicenter, Open-label Study To Compare On-demand Treatment To A Prophylaxis Regimen Of Nonacog-alfa (Benefix) In Subjects With Moderately Severe To Severe Hemophilia B (Fix:c</=2%)
In Brief
A Phase 3 clinical trial evaluating Nonacog alfa for Hemophilia B. Completed, enrolled 25 participants across 17 sites in 9 countries.
Detailed Summary
The purpose of this study will be to determine if a once-weekly prophylaxis regimen of BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesBulgaria, Canada, Croatia, Malaysia, Mexico, Poland, Singapore, South Korea, Turkey (Türkiye)
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2011
Enrollment StartSep 2011
Primary CompletionApr 2014
TodayJul 2026
First PostedApr 13, 2011
Enrollment StartSep 1, 2011
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.2 years ago
Interventions
Nonacog alfabiological
Period 1: During on-demand period, dosing at the discretion of investigator.
Nonacog alfabiological
Period 2: During the prophylaxis period, 100 IU/kg once weekly