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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

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.
ClinicalTrials.gov Identifier: NCT00426803
Recruitment Status : Completed
First Posted : January 25, 2007
Last Update Posted : January 18, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
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
Study Start Date : August 2002
Primary Completion Date : June 2004
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Reducing haematoma growth

Secondary Outcome Measures :
  1. Reducing disability and improving clinical outcome

Eligibility Criteria

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

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

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

Additional Information:

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

Additional relevant MeSH terms:
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