Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

January 17, 2017 updated by: Novo Nordisk A/S

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia, VIC 3052
        • Novo Nordisk Investigational Site
  • Austria
      • Graz, Austria, A-8036
        • Novo Nordisk Investigational Site
  • Belgium
      • Antwerpen, Belgium, 2020
        • Novo Nordisk Investigational Site
  • Canada
      • Calgary, Canada, AB T2N 2T9
        • Novo Nordisk Investigational Site
  • Denmark
      • Aarhus, Denmark, 8000
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00014
        • Novo Nordisk Investigational Site
  • Germany
      • Leipzig, Germany, SN04103
        • Novo Nordisk Investigational Site
  • Italy
      • Perugia, Italy, 06126
        • Novo Nordisk Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Novo Nordisk Investigational Site
  • Norway
      • Bergen, Norway, 5021
        • Novo Nordisk Investigational Site
  • Singapore
      • Singapore, Singapore, 308443
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28040
        • Novo Nordisk Investigational Site
  • Sweden
      • Stockholm, Sweden, 171 76
        • Novo Nordisk Investigational Site
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Newcastle Upon Tyne, United Kingdom, NE2 4HH
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reducing haematoma growth

Secondary Outcome Measures

Outcome Measure
Reducing disability and improving clinical outcome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

January 24, 2007

First Submitted That Met QC Criteria

January 24, 2007

First Posted (Estimate)

January 25, 2007

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7ICH-1371

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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