At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 829 enrolled
Drug / intervention
eptacog alfa (activated)drug
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.
Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in Acute Intracerebral Haemorrhage
In Brief
A Phase 3 clinical trial evaluating eptacog alfa (activated) for Acquired Bleeding Disorder and Intracerebral Haemorrhage. Completed, enrolled 829 participants across 167 sites in 23 countries.
Detailed Summary
This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America. The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, Brazil, Canada, China, Croatia, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Netherlands, Norway, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2005
First PostedAug 2005
Primary CompletionJan 2007
TodayJul 2026
First PostedAug 5, 2005
Enrollment StartMay 1, 2005
Primary CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 20.9 years ago
Interventions
eptacog alfa (activated)drug