At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 40 enrolled
Drug / intervention
Recombinant Factor VIIa BI (rFVIIa BI) +1 morebiological
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.
A PHASE 3, PROSPECTIVE, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE SAFETY AND EFFICACY OF RECOMBINANT ACTIVATED FVII BI (rFVIIa BI) IN THE TREATMENT OF ACUTE BLEEDING EPISODES PER AN ON-DEMAND REGIMEN IN PATIENTS WITH HEMOPHILIA A OR B WITH INHIBITORS
In Brief
A Phase 3 clinical trial evaluating Recombinant Factor VIIa BI (rFVIIa BI) for Hemophilia A and Hemophilia B. Completed, enrolled 40 participants across 16 sites in 9 countries.
Detailed Summary
The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A, Hemophilia B
CountriesJapan, Poland, Romania, Russia, Serbia, Spain, Taiwan, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartFeb 2013
Primary CompletionNov 2014
TodayJul 2026
First PostedDec 28, 2012
Enrollment StartFeb 20, 2013
Primary CompletionNov 11, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.5 years ago
Interventions
Recombinant Factor VIIa BI (rFVIIa BI)biological
Administered approximately every 3 hours as an intravenous bolus injection on-demand
Recombinant Factor VIIa BI (rFVIIa BI)biological
Administered as a single intravenous bolus injection on-demand