Recombinant Factor VIIa in Acute Intracerebral Haemorrhage (FAST)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00127283
First received: August 3, 2005
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America.

The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.


Condition Intervention Phase
Acquired Bleeding Disorder
Intracerebral Haemorrhage
Drug: activated recombinant human factor VII
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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 Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in Acute Intracerebral Haemorrhage

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Reducing disability and improving clinical outcome [ Time Frame: After 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reducing mortality [ Designated as safety issue: No ]
  • Reducing hematoma growth [ Designated as safety issue: No ]

Enrollment: 829
Study Start Date: May 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (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 hemorrhage (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: NCT00127283

  Show 71 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Nikolai C. Brun Novo Nordisk A/S
Study Director: Brett Skolnick, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00127283     History of Changes
Other Study ID Numbers: F7ICH-1641, 2004-004202-24
Study First Received: August 3, 2005
Last Updated: October 29, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Taiwan: Department of Health
Spain: Spanish Agency of Medicines
Singapore: Health Sciences Authority
Croatia: Ministry of Health and Social Care
Denmark: Danish Medicines Agency
Brazil: National Health Surveillance Agency
Canada: Health Canada
Finland: Finnish Medicines Agency
Netherlands: Dutch Health Care Inspectorate
Austria: Federal Ministry for Health and Women
Germany: Paul-Ehrlich-Institut
China: Food and Drug Administration
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Norway: Norwegian Medicines Agency
Thailand: Khon Kaen University Ethics Committee for Human Research
Sweden: Medical Products Agency
United States: Food and Drug Administration
Hong Kong: Department 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 October 01, 2014