Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

NCT ID: NCT00127283

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

829 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acquired Bleeding Disorder Intracerebral Haemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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eptacog alfa (activated)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with secondary ICH
* Pre-existing disability
* Haemophilia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Seattle, Washington, United States

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Madison, Wisconsin, United States

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Parkville, Victoria, Australia

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Camperdown, , Australia

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Fort Smith, Arkansas, United States

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Los Angeles, California, United States

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Oceanside, California, United States

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Orange, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

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Stanford, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Englewood, Colorado, United States

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Hartford, Connecticut, United States

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

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Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Tallahassee, Florida, United States

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Gosford, , Australia

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Decatur, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Maywood, Illinois, United States

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Peoria, Illinois, United States

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Fort Wayne, Indiana, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Golden Valley, Minnesota, United States

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Blackwater, Mississippi, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Lebanon, New Hampshire, United States

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Cherry Hill, New Jersey, United States

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Hackensack, New Jersey, United States

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Ridgewood, New Jersey, United States

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Buffalo, New York, United States

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New York, New York, United States

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Stony Brook, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Chattanooga, Tennessee, United States

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Hashville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Burlington, Vermont, United States

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Charlottesville, Virginia, United States

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Heidelberg Heights, , Australia

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Graz, , Austria

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Innsbruck, , Austria

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Antwerp, , Belgium

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Bruges, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Sao Cristóvao, , Brazil

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Vila Clementino, , Brazil

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Edmonton, Alberta, Canada

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Halifax, Nova Scotia, Canada

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Calgary, , Canada

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Greenfield Park, , Canada

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London, , Canada

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Mississauga, , Canada

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Ottawa, , Canada

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Saint John, , Canada

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Saskatoon, , Canada

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Thunder Bay, , Canada

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Toronto, , Canada

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Vancouver, , Canada

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Beijing, Beijing Municipality, China

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Shanghai, Shanghai Municipality, China

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Shanghai, Shanghai Municipality, China

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Zagreb, , Croatia

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Aalborg, , Denmark

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Aarhus, , Denmark

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Copenhagen, , Denmark

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Glostrup Municipality, , Denmark

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Helsinki, , Finland

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Kuopio, , Finland

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Seinäjoki, , Finland

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Turku, , Finland

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Bordeaux, , France

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Berlin, , Germany

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Heidelberg, , Germany

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Minden, , Germany

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Münster, , Germany

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Hong Kong, , Hong Kong

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Florence, , Italy

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Pavia, , Italy

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Perugia, , Italy

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Roma, , Italy

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Amsterdam, , Netherlands

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Amsterdam, , Netherlands

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Eindhoven, , Netherlands

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Heerlen, , Netherlands

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Rotterdam, , Netherlands

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Utrecht, , Netherlands

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Bergen, , Norway

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Kristiansand, , Norway

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Nordbyhagen, , Norway

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Stavanger, , Norway

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Trondheim, , Norway

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Singapore, , Singapore

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Singapore, , Singapore

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Badalona, , Spain

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Barcelona, , Spain

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Girona, , Spain

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Madrid, , Spain

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Linköping, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Umeå, , Sweden

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Lausanne, , Switzerland

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Bangkok, , Thailand

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Bangkok, , Thailand

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Countries

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United States Australia Austria Belgium Brazil Canada China Croatia Denmark Finland France Germany Hong Kong Israel Italy Netherlands Norway Singapore Spain Sweden Switzerland Taiwan Thailand

References

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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.

Reference Type RESULT
PMID: 18580208 (View on PubMed)

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.

Reference Type RESULT
PMID: 18480205 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37870112 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2004-004202-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

F7ICH-1641

Identifier Type: -

Identifier Source: org_study_id

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