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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00426803
First received: January 24, 2007
Last updated: June 26, 2012
Last verified: September 2011
History of Changes
  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
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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426803

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

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, 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: 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
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Cerebral Hemorrhage
Hematologic Diseases
Vascular Diseases
 Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013