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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00426803
First received: January 24, 2007
Last updated: January 17, 2017
Last verified: January 2017
  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 Blind (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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 24, 2007
Last Updated: January 17, 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

ClinicalTrials.gov processed this record on July 28, 2017