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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00426803
First Posted: January 25, 2007
Last Update Posted: January 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Acquired Bleeding Disorder Intracerebral Haemorrhage Drug: activated recombinant human factor VII Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Reducing haematoma growth

Secondary Outcome Measures:
  • Reducing disability and improving clinical outcome

Enrollment: 400
Study Start Date: August 2002
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with secondary ICH
  • Pre-existing disability
  • Haemophilia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426803


Locations
Australia
Novo Nordisk Investigational Site
Melbourne, Australia, VIC 3052
Austria
Novo Nordisk Investigational Site
Graz, Austria, A-8036
Belgium
Novo Nordisk Investigational Site
Antwerpen, Belgium, 2020
Canada
Novo Nordisk Investigational Site
Calgary, Canada, AB T2N 2T9
Denmark
Novo Nordisk Investigational Site
Aarhus, Denmark, 8000
Finland
Novo Nordisk Investigational Site
Helsinki, Finland, 00014
Germany
Novo Nordisk Investigational Site
Leipzig, Germany, SN04103
Italy
Novo Nordisk Investigational Site
Perugia, Italy, 06126
Netherlands
Novo Nordisk Investigational Site
Amsterdam, Netherlands, 1105
Norway
Novo Nordisk Investigational Site
Bergen, Norway, 5021
Singapore
Novo Nordisk Investigational Site
Singapore, Singapore, 308443
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28040
Sweden
Novo Nordisk Investigational Site
Stockholm, Sweden, 171 76
Switzerland
Novo Nordisk Investigational Site
Lausanne, Switzerland, 1011
United Kingdom
Novo Nordisk Investigational Site
Newcastle Upon Tyne, United Kingdom, NE2 4HH
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00426803     History of Changes
Other Study ID Numbers: F7ICH-1371
First Submitted: January 24, 2007
First Posted: January 25, 2007
Last Update Posted: January 18, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders