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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: January 24, 2007
Last updated: January 17, 2017
Last verified: January 2017
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reducing disability and improving clinical outcome [ Designated as safety issue: No ]

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
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 identifier: 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 Identifier: NCT00426803     History of Changes
Other Study ID Numbers: F7ICH-1371 
Study First Received: January 24, 2007
Last Updated: January 17, 2017
Health Authority: Taiwan: Department of Health
Spain: Spanish Agency of Medicines
Singapore: Health Sciences Authority
United Kingdom: Medicines Control Agency
Croatia: Ministry of Health and Social Care
Denmark: Danish Medicines Agency
Canada: Health Canada
Finland: Finnish Medicines Agency
Netherlands: Dutch Health Care Inspectorate
New Zealand: Food Safety Authority
Austria: Federal Ministry for Health and Women
Germany: Paul-Ehrlich-Institut
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Switzerland: Swissmedic
Australia: Department of Health and Ageing Therapeutic Goods Administration
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
United States: Food and Drug Administration
Malaysia: Ministry of Health

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 processed this record on January 18, 2017