Recombinant Factor VIIa in Acute Intracerebral Haemorrhage (FAST)

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

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.

Study Overview

• Status: Completed
• Conditions: Acquired Bleeding Disorder; Intracerebral Haemorrhage
• Intervention / Treatment: Drug: eptacog alfa (activated)

• Study Type: Interventional
• Enrollment (Actual): 829
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Camperdown, Australia, 2050
    • Novo Nordisk Investigational Site
  • Gosford, Australia, 2250
    • Novo Nordisk Investigational Site
  • Heidelberg Heights, Australia, 3081
    • Novo Nordisk Investigational Site
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • Novo Nordisk Investigational Site
• Austria
  • Graz, Austria, 8036
    • Novo Nordisk Investigational Site
  • Innsbruck, Austria, 6020
    • Novo Nordisk Investigational Site
• Belgium
  • Antwerpen, Belgium, 2020
    • Novo Nordisk Investigational Site
  • Brugge, Belgium, 8000
    • Novo Nordisk Investigational Site
  • Brussels, Belgium, 1200
    • Novo Nordisk Investigational Site
  • Brussels, Belgium, 1070
    • Novo Nordisk Investigational Site
• Brazil
  • Sao Cristóvao, Brazil, 20941-150
    • Novo Nordisk Investigational Site
  • Vila Clementino, Brazil, 04039-032
    • Novo Nordisk Investigational Site
• Canada
  • 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
    • Novo Nordisk Investigational Site
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Novo Nordisk Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Novo Nordisk Investigational Site
• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Novo Nordisk Investigational Site
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Novo Nordisk Investigational Site
    • Shanghai, Shanghai, China, 200001
      • Novo Nordisk Investigational Site
• Croatia
  • Zagreb, Croatia, 10000
    • Novo Nordisk Investigational Site
• Denmark
  • Aalborg, Denmark, 9100
    • Novo Nordisk Investigational Site
  • Copenhagen, Denmark
    • Novo Nordisk Investigational Site
  • Glostrup, Denmark, 2600
    • Novo Nordisk Investigational Site
  • Århus, Denmark, 8000
    • Novo Nordisk Investigational Site
• Finland
  • 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
    • Novo Nordisk Investigational Site
• France
  • 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
    • Novo Nordisk Investigational Site
• Germany
  • 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
    • Novo Nordisk Investigational Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Novo Nordisk Investigational Site
• Israel
  • Tel Aviv, Israel, 64239
    • Novo Nordisk Investigational Site
  • Tel Hashomer, Israel, 52621
    • Novo Nordisk Investigational Site
• Italy
  • Firenze, Italy, 50134
    • Novo Nordisk Investigational Site
  • Pavia, Italy, 27100
    • Novo Nordisk Investigational Site
  • Perugia, Italy, 06156
    • Novo Nordisk Investigational Site
  • Roma, Italy, 00185
    • Novo Nordisk Investigational Site
• Netherlands
  • 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
    • Novo Nordisk Investigational Site
• Norway
  • 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
    • Novo Nordisk Investigational Site
• Singapore
  • Singapore, Singapore, 119074
    • Novo Nordisk Investigational Site
  • Singapore, Singapore, 308443
    • Novo Nordisk Investigational Site
• Spain
  • 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
    • Novo Nordisk Investigational Site
• Sweden
  • Linköping, Sweden, 581 85
    • Novo Nordisk Investigational Site
  • Malmö, Sweden, 214 28
    • Novo Nordisk Investigational Site
  • Stockholm, Sweden, 171 76
    • Novo Nordisk Investigational Site
  • Stockholm, Sweden, 141 86
    • Novo Nordisk Investigational Site
  • Stockholm, Sweden, 118 83
    • Novo Nordisk Investigational Site
  • Umeå, Sweden, 901 85
    • Novo Nordisk Investigational Site
• Switzerland
  • Lausanne, Switzerland, 1011
    • Novo Nordisk Investigational Site
• Taiwan
  • Taipei, Taiwan, 100
    • Novo Nordisk Investigational Site
  • Taipei, Taiwan, 114
    • Novo Nordisk Investigational Site
  • Taoyuan, Taiwan, 333
    • Novo Nordisk Investigational Site
• Thailand
  • Bangkok, Thailand, 10400
    • Novo Nordisk Investigational Site
  • Bangkok, Thailand, 10330
    • Novo Nordisk Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Novo Nordisk Investigational Site
    • Mobile, Alabama, United States, 36617
      • Novo Nordisk Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Novo Nordisk Investigational Site
  • Arkansas
    • Fort Smith, Arkansas, United States, 72901
      • Novo Nordisk Investigational Site
  • California
    • 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
      • Novo Nordisk Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80262
      • Novo Nordisk Investigational Site
    • Denver, Colorado, United States, 80204
      • Novo Nordisk Investigational Site
    • Englewood, Colorado, United States, 80113
      • Novo Nordisk Investigational Site
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Novo Nordisk Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Novo Nordisk Investigational Site
  • Florida
    • 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
      • Novo Nordisk Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30320
      • Novo Nordisk Investigational Site
    • Augusta, Georgia, United States, 30912-3260
      • Novo Nordisk Investigational Site
    • Decatur, Georgia, United States, 33033
      • Novo Nordisk Investigational Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Novo Nordisk Investigational Site
  • Illinois
    • 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
      • Novo Nordisk Investigational Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46805
      • Novo Nordisk Investigational Site
    • Indianapolis, Indiana, United States, 46260
      • Novo Nordisk Investigational Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Novo Nordisk Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Novo Nordisk Investigational Site
    • Louisville, Kentucky, United States, 40202
      • Novo Nordisk Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Novo Nordisk Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Novo Nordisk Investigational Site
    • Boston, Massachusetts, United States, 02118
      • Novo Nordisk Investigational Site
    • Boston, Massachusetts, United States, 02144
      • Novo Nordisk Investigational Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Novo Nordisk Investigational Site
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Novo Nordisk Investigational Site
  • Mississippi
    • Jacksonville, Mississippi, United States, 39216
      • Novo Nordisk Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Novo Nordisk Investigational Site
    • St. Louis, Missouri, United States, 63110
      • Novo Nordisk Investigational Site
    • St. Louis, Missouri, United States, 63110-1010
      • Novo Nordisk Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Novo Nordisk Investigational Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-0001
      • Novo Nordisk Investigational Site
  • New Jersey
    • 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
      • Novo Nordisk Investigational Site
  • New York
    • 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
      • Novo Nordisk Investigational Site
  • North Carolina
    • 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
      • Novo Nordisk Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Novo Nordisk Investigational Site
    • Cleveland, Ohio, United States, 44195
      • Novo Nordisk Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Novo Nordisk Investigational Site
    • Portland, Oregon, United States, 97225
      • Novo Nordisk Investigational Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103-6208
      • Novo Nordisk Investigational Site
    • Philadelphia, Pennsylvania, United States, 19107
      • Novo Nordisk Investigational Site
    • Philadelphia, Pennsylvania, United States, 19104
      • Novo Nordisk Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15212-4746
      • Novo Nordisk Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213-2546
      • Novo Nordisk Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Novo Nordisk Investigational Site
  • Tennessee
    • 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
      • Novo Nordisk Investigational Site
  • Texas
    • 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
      • Novo Nordisk Investigational Site
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Novo Nordisk Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Novo Nordisk Investigational Site
  • Washington
    • Seattle, Washington, United States, 98102
      • Novo Nordisk Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-3236
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Spontaneous intracranial hemorrhage (ICH) within 3 hours after first symptom

Exclusion Criteria:

• Patients with secondary ICH
• Pre-existing disability
• Haemophilia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reducing disability and improving clinical outcome	After 3 months

Secondary Outcome Measures

Outcome Measure
Reducing mortality
Reducing hematoma growth

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; FAST Trial Investigators. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008 May 15;358(20):2127-37. doi: 10.1056/NEJMoa0707534.
• Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: August 3, 2005
• First Submitted That Met QC Criteria: August 3, 2005
• First Posted (Estimate): August 5, 2005

Study Record Updates

• Last Update Posted (Estimate): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Hemorrhagic Disorders; Intracranial Hemorrhages; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: F7ICH-1641; 2004-004202-24 (EudraCT Number)