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Clinical Trials/NCT00127283
NCT00127283
Completed
Phase 3

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

Novo Nordisk A/S1 site in 1 country829 target enrollmentMay 2005
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ConditionsAcquired Bleeding DisorderIntracerebral Haemorrhage
Drugseptacog alfa (activated)

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Acquired Bleeding Disorder
Sponsor
Novo Nordisk A/S
Enrollment
829
Locations
1
Primary Endpoint
Reducing disability and improving clinical outcome
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 2005
End Date
January 2007
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Spontaneous intracranial hemorrhage (ICH) within 3 hours after first symptom

Exclusion Criteria

  • •Patients with secondary ICH
  • •Pre-existing disability
  • •Haemophilia

Outcomes

Primary Outcomes

Reducing disability and improving clinical outcome

Time Frame: After 3 months

Secondary Outcomes

  • Reducing mortality
  • Reducing hematoma growth

Study Sites (1)

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