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Clinical Trials/NCT00123591
NCT00123591CompletedPhase 2

A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa (NovoSeven®/NiaStase®) in Subjects With Brain Contusions

Novo Nordisk A/S15 sites in 11 countries96 target enrollmentStarted: January 1, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
96
Locations
15
Primary Endpoint
Evaluate the Safety of Recombinant Activated Factor VII in Subjects with Brain Contusions
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This trial is conducted in Asia, Europe, Middle East, and North America. The primary objective of the trial is to evaluate the safety of Recombinant Activated Factor VII in patients with brain contusions. The secondary objective of the trial is to evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing early haemorrhagic progression in contusive brain injury.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Contusive brain injury (including brain stem) diagnosed by history, clinical examination and confirmed by CT scan within 6 hours of onset
  • •In British Columbia and Nova Scotia, subjects must be = 19 years.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Evaluate the Safety of Recombinant Activated Factor VII in Subjects with Brain Contusions

Time Frame: Within the first 15 days of injury

Secondary Outcomes

  • Evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing haemorrhagic progression in brain contusions

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (15)

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