Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

NCT00127283 | Completed Phase 3

• 2 other identifiers: F7ICH-16412004-004202-24
• Study Type: interventional
• Target: 829
• Locations: 22 countries
• Sites: 163

Brief Summary

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.

Conditions

Acquired Bleeding Disorder; Intracerebral Haemorrhage

Outcome Measures

Primary Outcomes (1)

• Reducing disability and improving clinical outcome

  After 3 months

Secondary Outcomes (2)

• Reducing mortality

• Reducing hematoma growth

Interventions

eptacog alfa (activated) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (167)

Novo Nordisk Investigational Site

Birmingham, Alabama, 35209, United States

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Mobile, Alabama, 36617, United States

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Phoenix, Arizona, 85013, United States

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Fort Smith, Arkansas, 72901, United States

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Los Angeles, California, 90024, United States

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Oceanside, California, 92056, United States

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Orange, California, 92868-4280, United States

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Sacramento, California, 95816, United States

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San Diego, California, 92103, United States

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San Francisco, California, 94110-3594, United States

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San Francisco, California, 94143-0780, United States

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Stanford, California, 94305, United States

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Denver, Colorado, 80204, United States

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Denver, Colorado, 80262, United States

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Englewood, Colorado, 80113, United States

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Hartford, Connecticut, 06102, United States

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Washington D.C., District of Columbia, 20010, United States

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Jacksonville, Florida, 32209, United States

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Melbourne, Florida, 32901, United States

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Tallahassee, Florida, 32308, United States

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Tampa, Florida, 33606, United States

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Atlanta, Georgia, 30320, United States

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Augusta, Georgia, 30912-3260, United States

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Decatur, Georgia, 33033, United States

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Honolulu, Hawaii, 96813, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60612, United States

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Maywood, Illinois, 60153, United States

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Peoria, Illinois, 61637, United States

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Fort Wayne, Indiana, 46805, United States

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Indianapolis, Indiana, 46260, United States

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Iowa City, Iowa, 52242, United States

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Lexington, Kentucky, 40536, United States

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Louisville, Kentucky, 40202, United States

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Baltimore, Maryland, 21287, United States

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Boston, Massachusetts, 02118, United States

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Boston, Massachusetts, 02144, United States

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Boston, Massachusetts, 02215, United States

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Detroit, Michigan, 48201, United States

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Golden Valley, Minnesota, 55422, United States

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Blackwater, Mississippi, 39216, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63110-1010, United States

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St Louis, Missouri, 63110, United States

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Las Vegas, Nevada, 89109, United States

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Lebanon, New Hampshire, 03756-0001, United States

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Cherry Hill, New Jersey, 08034, United States

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Hackensack, New Jersey, 07465, United States

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Ridgewood, New Jersey, 07450, United States

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Buffalo, New York, 14215, United States

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New York, New York, 10032, United States

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Stony Brook, New York, 11794-8121, United States

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Chapel Hill, North Carolina, 27599-7025, United States

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Charlotte, North Carolina, 28232-2861, United States

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Durham, North Carolina, 27705, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45267, United States

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Cleveland, Ohio, 44195, United States

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Portland, Oregon, 97225, United States

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Portland, Oregon, 97239, United States

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Allentown, Pennsylvania, 18103-6208, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Pittsburgh, Pennsylvania, 15212-4746, United States

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Pittsburgh, Pennsylvania, 15213-2546, United States

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Charleston, South Carolina, 29425, United States

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Chattanooga, Tennessee, 37403, United States

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Hashville, Tennessee, 37232, United States

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Memphis, Tennessee, 38163, United States

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Nashville, Tennessee, 37205, United States

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Dallas, Texas, 75390-8897, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Burlington, Vermont, 05401, United States

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Charlottesville, Virginia, 22908, United States

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Seattle, Washington, 98102, United States

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Madison, Wisconsin, 53792-3236, United States

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Parkville, Victoria, 3052, Australia

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Camperdown, 2050, Australia

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Gosford, 2250, Australia

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Heidelberg Heights, 3081, Australia

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Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Antwerp, 2020, Belgium

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Bruges, 8000, Belgium

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Brussels, 1070, Belgium

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Brussels, 1200, Belgium

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Sao Cristóvao, 20941-150, Brazil

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Vila Clementino, 04039-032, Brazil

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Edmonton, Alberta, T6G 2B7, Canada

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Halifax, Nova Scotia, B3H 3A7, Canada

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Calgary, T2N 2T9, Canada

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Greenfield Park, J4V 2H1, Canada

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London, N6A 5A5, Canada

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Mississauga, L5B 1B8, Canada

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Montreal, H2L 4M1, Canada

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Montreal, H3A 2B4, Canada

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Ottawa, KIH 8L6, Canada

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Québec, G1J 1Z4, Canada

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Saint John, E2L 4L2, Canada

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Saskatoon, S7N 0W8, Canada

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Thunder Bay, P7B 6V4, Canada

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Toronto, M4N 3M5, Canada

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Vancouver, V5Z 3J5, Canada

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Beijing, Beijing Municipality, 100050, China

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Shanghai, Shanghai Municipality, 200001, China

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Shanghai, Shanghai Municipality, 200040, China

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Zagreb, 10000, Croatia

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Aalborg, 9100, Denmark

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Aarhus, 8000, Denmark

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Copenhagen, Denmark

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Glostrup Municipality, 2600, Denmark

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Helsinki, FI-00029, Finland

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Kuopio, FI-70211, Finland

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Seinäjoki, FI-60220, Finland

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Turku, FI-20521, Finland

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Bordeaux, 33076, France

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Paris, 75010, France

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Paris, 75013, France

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Paris, 75877, France

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Toulouse, 31054, France

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Berlin, 13353, Germany

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Dresden, 01307, Germany

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Essen, 45147, Germany

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Heidelberg, 69120, Germany

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Leipzig, 04103, Germany

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Mannheim, 68167, Germany

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Minden, 32427, Germany

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München, 81545, Germany

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Münster, 48149, Germany

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Hong Kong, Hong Kong

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Tel Aviv, 64239, Israel

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Tel Litwinsky, 52621, Israel

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Florence, 50134, Italy

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Pavia, 27100, Italy

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Perugia, 06156, Italy

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Roma, 00185, Italy

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Amsterdam, 1066 EC, Netherlands

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Amsterdam, 1105 AZ, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Heerlen, 6419 PC, Netherlands

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Rotterdam, 3015 GD, Netherlands

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Utrecht, 3584 CX, Netherlands

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Bergen, 5021, Norway

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Kristiansand, 4604, Norway

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Nordbyhagen, 1474, Norway

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Stavanger, NO-4011, Norway

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Trondheim, NO-7030, Norway

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Singapore, 119074, Singapore

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Singapore, 308443, Singapore

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Badalona, 08916, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Girona, 17007, Spain

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Madrid, 28040, Spain

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Linköping, 581 85, Sweden

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Malmo, 214 28, Sweden

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Stockholm, 118 83, Sweden

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Stockholm, 141 86, Sweden

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Stockholm, 171 76, Sweden

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Umeå, 901 85, Sweden

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Lausanne, 1011, Switzerland

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Taipei, 100, Taiwan

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Taipei, 114, Taiwan

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Taoyuan District, 333, Taiwan

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Bangkok, 10330, Thailand

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Bangkok, 10400, Thailand

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Related Publications (3)

• 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.

  PMID: 18580208 RESULT

• 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.

  PMID: 18480205 RESULT

• Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.

  PMID: 37870112 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Factor VII

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2005
• First Posted: August 5, 2005
• Study Start: May 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

IL (2); CN (3); AU (2); US (77); DE (9); FR (5); HK (1); BE (4); CA (15); BR (2); FI (4); CR (1); IT (4); NO (5); SG (2); ES (5); SE (6); CH (1); TW (3); DK (4); NL (6); TH (2)