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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage (FAST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127283
First Posted: August 5, 2005
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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 (eptacog alfa (activated)) 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: eptacog alfa (activated) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Reducing mortality
  • Reducing hematoma growth

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127283


  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35209
Novo Nordisk Investigational Site
Mobile, Alabama, United States, 36617
United States, Arizona
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85013
United States, Arkansas
Novo Nordisk Investigational Site
Fort Smith, Arkansas, United States, 72901
United States, California
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90024
Novo Nordisk Investigational Site
Oceanside, California, United States, 92056
Novo Nordisk Investigational Site
Orange, California, United States, 92868-4280
Novo Nordisk Investigational Site
Sacramento, California, United States, 95816
Novo Nordisk Investigational Site
San Diego, California, United States, 92103
Novo Nordisk Investigational Site
San Francisco, California, United States, 94110-3594
Novo Nordisk Investigational Site
San Francisco, California, United States, 94143-0780
Novo Nordisk Investigational Site
Stanford, California, United States, 94305
United States, Colorado
Novo Nordisk Investigational Site
Denver, Colorado, United States, 80204
Novo Nordisk Investigational Site
Denver, Colorado, United States, 80262
Novo Nordisk Investigational Site
Englewood, Colorado, United States, 80113
United States, Connecticut
Novo Nordisk Investigational Site
Hartford, Connecticut, United States, 06102
United States, District of Columbia
Novo Nordisk Investigational Site
Washington, District of Columbia, United States, 20010
United States, Florida
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32209
Novo Nordisk Investigational Site
Melbourne, Florida, United States, 32901
Novo Nordisk Investigational Site
Tallahassee, Florida, United States, 32308
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33606
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30320
Novo Nordisk Investigational Site
Augusta, Georgia, United States, 30912-3260
Novo Nordisk Investigational Site
Decatur, Georgia, United States, 33033
United States, Hawaii
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States, 96813
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60611
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60612
Novo Nordisk Investigational Site
Maywood, Illinois, United States, 60153
Novo Nordisk Investigational Site
Peoria, Illinois, United States, 61637
United States, Indiana
Novo Nordisk Investigational Site
Fort Wayne, Indiana, United States, 46805
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Iowa
Novo Nordisk Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40536
Novo Nordisk Investigational Site
Louisville, Kentucky, United States, 40202
United States, Maryland
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02118
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02144
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02215
United States, Michigan
Novo Nordisk Investigational Site
Detroit, Michigan, United States, 48201
United States, Minnesota
Novo Nordisk Investigational Site
Golden Valley, Minnesota, United States, 55422
United States, Mississippi
Novo Nordisk Investigational Site
Jacksonville, Mississippi, United States, 39216
United States, Missouri
Novo Nordisk Investigational Site
Kansas City, Missouri, United States, 64111
Novo Nordisk Investigational Site
St. Louis, Missouri, United States, 63110-1010
Novo Nordisk Investigational Site
St. Louis, Missouri, United States, 63110
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89109
United States, New Hampshire
Novo Nordisk Investigational Site
Lebanon, New Hampshire, United States, 03756-0001
United States, New Jersey
Novo Nordisk Investigational Site
Cherry Hill, New Jersey, United States, 08034
Novo Nordisk Investigational Site
Hackensack, New Jersey, United States, 07465
Novo Nordisk Investigational Site
Ridgewood, New Jersey, United States, 07450
United States, New York
Novo Nordisk Investigational Site
Buffalo, New York, United States, 14215
Novo Nordisk Investigational Site
New York, New York, United States, 10032
Novo Nordisk Investigational Site
Stony Brook, New York, United States, 11794-8121
United States, North Carolina
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States, 27599-7025
Novo Nordisk Investigational Site
Charlotte, North Carolina, United States, 28232-2861
Novo Nordisk Investigational Site
Durham, North Carolina, United States, 27705
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45267
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44195
United States, Oregon
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97225
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Novo Nordisk Investigational Site
Allentown, Pennsylvania, United States, 18103-6208
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15212-4746
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15213-2546
United States, South Carolina
Novo Nordisk Investigational Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37403
Novo Nordisk Investigational Site
Hashville, Tennessee, United States, 37232
Novo Nordisk Investigational Site
Memphis, Tennessee, United States, 38163
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37205
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-8897
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229
United States, Vermont
Novo Nordisk Investigational Site
Burlington, Vermont, United States, 05401
United States, Virginia
Novo Nordisk Investigational Site
Charlottesville, Virginia, United States, 22908
United States, Washington
Novo Nordisk Investigational Site
Seattle, Washington, United States, 98102
United States, Wisconsin
Novo Nordisk Investigational Site
Madison, Wisconsin, United States, 53792-3236
Australia, Victoria
Novo Nordisk Investigational Site
Parkville, Victoria, Australia, 3052
Australia
Novo Nordisk Investigational Site
Camperdown, Australia, 2050
Novo Nordisk Investigational Site
Gosford, Australia, 2250
Novo Nordisk Investigational Site
Heidelberg Heights, Australia, 3081
Austria
Novo Nordisk Investigational Site
Graz, Austria, 8036
Novo Nordisk Investigational Site
Innsbruck, Austria, 6020
Belgium
Novo Nordisk Investigational Site
Antwerpen, Belgium, 2020
Novo Nordisk Investigational Site
Brugge, Belgium, 8000
Novo Nordisk Investigational Site
Brussels, Belgium, 1070
Novo Nordisk Investigational Site
Brussels, Belgium, 1200
Brazil
Novo Nordisk Investigational Site
Sao Cristóvao, Brazil, 20941-150
Novo Nordisk Investigational Site
Vila Clementino, Brazil, 04039-032
Canada, Alberta
Novo Nordisk Investigational Site
Edmonton, Alberta, Canada, T6G 2B7
Canada, Nova Scotia
Novo Nordisk Investigational Site
Halifax, Nova Scotia, Canada, B3H 3A7
Canada
Novo Nordisk Investigational Site
Calgary, Canada, T2N 2T9
Novo Nordisk Investigational Site
Greenfield Park, Canada, J4V 2H1
Novo Nordisk Investigational Site
London, Canada, N6A 5A5
Novo Nordisk Investigational Site
Mississauga, Canada, L5B 1B8
Novo Nordisk Investigational Site
Montreal, Canada, H2L 4M1
Novo Nordisk Investigational Site
Montreal, Canada, H3A 2B4
Novo Nordisk Investigational Site
Ottawa, Canada, KIH 8L6
Novo Nordisk Investigational Site
Quebec, Canada, G1J 1Z4
Novo Nordisk Investigational Site
Saint John, Canada, E2L 4L2
Novo Nordisk Investigational Site
Saskatoon, Canada, S7N 0W8
Novo Nordisk Investigational Site
Thunder Bay, Canada, P7B 6V4
Novo Nordisk Investigational Site
Toronto, Canada, M4N 3M5
Novo Nordisk Investigational Site
Vancouver, Canada, V5Z 3J5
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100050
China, Shanghai
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200001
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200040
Croatia
Novo Nordisk Investigational Site
Zagreb, Croatia, 10000
Denmark
Novo Nordisk Investigational Site
Aalborg, Denmark, 9100
Novo Nordisk Investigational Site
Copenhagen, Denmark
Novo Nordisk Investigational Site
Glostrup, Denmark, 2600
Novo Nordisk Investigational Site
Århus, Denmark, 8000
Finland
Novo Nordisk Investigational Site
Helsinki, Finland, FI-00029
Novo Nordisk Investigational Site
Kuopio, Finland, FI-70211
Novo Nordisk Investigational Site
Seinäjoki, Finland, FI-60220
Novo Nordisk Investigational Site
Turku, Finland, FI-20521
France
Novo Nordisk Investigational Site
Bordeaux, France, 33076
Novo Nordisk Investigational Site
Paris, France, 75010
Novo Nordisk Investigational Site
Paris, France, 75013
Novo Nordisk Investigational Site
Paris, France, 75877
Novo Nordisk Investigational Site
TOULOUSE cedex, France, 31054
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 13353
Novo Nordisk Investigational Site
Dresden, Germany, 01307
Novo Nordisk Investigational Site
Essen, Germany, 45147
Novo Nordisk Investigational Site
Heidelberg, Germany, 69120
Novo Nordisk Investigational Site
Leipzig, Germany, 04103
Novo Nordisk Investigational Site
Mannheim, Germany, 68167
Novo Nordisk Investigational Site
Minden, Germany, 32427
Novo Nordisk Investigational Site
München, Germany, 81545
Novo Nordisk Investigational Site
Münster, Germany, 48149
Hong Kong
Novo Nordisk Investigational Site
Hong Kong, Hong Kong
Israel
Novo Nordisk Investigational Site
Tel Aviv, Israel, 64239
Novo Nordisk Investigational Site
Tel Hashomer, Israel, 52621
Italy
Novo Nordisk Investigational Site
Firenze, Italy, 50134
Novo Nordisk Investigational Site
Pavia, Italy, 27100
Novo Nordisk Investigational Site
Perugia, Italy, 06156
Novo Nordisk Investigational Site
Roma, Italy, 00185
Netherlands
Novo Nordisk Investigational Site
Amsterdam, Netherlands, 1066 EC
Novo Nordisk Investigational Site
Amsterdam, Netherlands, 1105 AZ
Novo Nordisk Investigational Site
Eindhoven, Netherlands, 5623 EJ
Novo Nordisk Investigational Site
Heerlen, Netherlands, 6419 PC
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3015 GD
Novo Nordisk Investigational Site
Utrecht, Netherlands, 3584 CX
Norway
Novo Nordisk Investigational Site
Bergen, Norway, 5021
Novo Nordisk Investigational Site
Kristiansand S, Norway, 4604
Novo Nordisk Investigational Site
Nordbyhagen, Norway, 1474
Novo Nordisk Investigational Site
Stavanger, Norway, NO-4011
Novo Nordisk Investigational Site
Trondheim, Norway, NO-7030
Singapore
Novo Nordisk Investigational Site
Singapore, Singapore, 119074
Novo Nordisk Investigational Site
Singapore, Singapore, 308443
Spain
Novo Nordisk Investigational Site
Badalona, Spain, 08916
Novo Nordisk Investigational Site
Barcelona, Spain, 08035
Novo Nordisk Investigational Site
Barcelona, Spain, 08036
Novo Nordisk Investigational Site
Girona, Spain, 17007
Novo Nordisk Investigational Site
Madrid, Spain, 28040
Sweden
Novo Nordisk Investigational Site
Linköping, Sweden, 581 85
Novo Nordisk Investigational Site
Malmö, Sweden, 214 28
Novo Nordisk Investigational Site
Stockholm, Sweden, 118 83
Novo Nordisk Investigational Site
Stockholm, Sweden, 141 86
Novo Nordisk Investigational Site
Stockholm, Sweden, 171 76
Novo Nordisk Investigational Site
Umeå, Sweden, 901 85
Switzerland
Novo Nordisk Investigational Site
Lausanne, Switzerland, 1011
Taiwan
Novo Nordisk Investigational Site
Taipei, Taiwan, 100
Novo Nordisk Investigational Site
Taipei, Taiwan, 114
Novo Nordisk Investigational Site
Taoyuan, Taiwan, 333
Thailand
Novo Nordisk Investigational Site
Bangkok, Thailand, 10330
Novo Nordisk Investigational Site
Bangkok, Thailand, 10400
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00127283     History of Changes
Other Study ID Numbers: F7ICH-1641
2004-004202-24 ( EudraCT Number )
First Submitted: August 3, 2005
First Posted: August 5, 2005
Last Update Posted: January 12, 2017
Last Verified: January 2017

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