Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: January 24, 2007
Last updated: June 26, 2012
Last verified: September 2011
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
Genders Eligible for Study:   Both
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

  Show 36 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Nicolai C. Brun, MD, Ph.D Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT00426803     History of Changes
Other Study ID Numbers: F7ICH-1371 
Study First Received: January 24, 2007
Last Updated: June 26, 2012
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:
Blood Coagulation Disorders
Cerebral Hemorrhage
Hemostatic Disorders
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Hematologic Diseases
Hemorrhagic Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases processed this record on May 26, 2016