Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

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


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)
  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
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

  Hide Study Locations
Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Palo Alto, California, United States, 94304
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92103-8466
United States, Hawaii
Novo Nordisk Clinical Trial Call Center
Honolulu, Hawaii, United States, 96813
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Boston, Massachusetts, United States, 02114
United States, New York
Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 11040
Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 10032
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Durham, North Carolina, United States, 27705
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45267-0525
United States, Oregon
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, United States, 97201
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Richmond, Virginia, United States, 23226
Australia
Parkville, Australia, 3050
Austria
Graz, Austria, 8036
Belgium
Antwerpen, Belgium, 2020
Canada
Calgary, Canada, T2N 2T9
Mississauga, Canada, L5B 1B8
Saint John, Canada, E2L 4L2
Saskatoon, Canada, S7N 0W8
Toronto, Canada, M5G-2C4
Vancouver, Canada, V5Z 3J5
Croatia
Zagreb, Croatia, 10 000
Denmark
Aarhus, Denmark, 8000 C
Finland
Helsinki, Finland
Germany
Heidelberg, Germany, 69115
Italy
Perugia, Italy, 06126
Malaysia
Kuala Lumpur, Malaysia, 56000
Netherlands
Amsterdam, Netherlands, 1105 AZ
New Zealand
Otahuhu, Auckland, New Zealand
Norway
Bergen, Norway, 5021
Singapore
Singapore, Singapore, 308443
Spain
Girona, Spain, 17007
Sweden
Stockholm, Sweden, 118 83
Switzerland
Lausanne, Switzerland, 1011
Taiwan
Geuishang Shiang, Taiwan, 333
United Kingdom
Newcastle upon Tyne, United Kingdom
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Nicolai C. Brun, MD, Ph.D Novo Nordisk A/S
  More Information

Additional Information:
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:
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 September 16, 2014