At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 400 enrolled
Drug / intervention
activated recombinant human factor VIIdrug
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, Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage
In Brief
A Phase 2 clinical trial evaluating activated recombinant human factor VII for Acquired Bleeding Disorder and Intracerebral Haemorrhage. Completed, enrolled 400 participants across 15 sites in 15 countries.
Detailed Summary
This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, Canada, Denmark, Finland, Germany, Italy, Netherlands, Norway, Singapore, Spain, Sweden, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2002
Primary CompletionJun 2004
First PostedJan 2007
TodayJul 2026
First PostedJan 25, 2007
Enrollment StartAug 1, 2002
Primary CompletionJun 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.4 years ago
Interventions
activated recombinant human factor VIIdrug