Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular Coagulation
NCT ID: NCT00487656
Last Updated: 2011-05-18
Study Results
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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COMPLETED
PHASE2
750 participants
INTERVENTIONAL
2007-07-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ART-123
6 mg/ml ampule solution for injection
ART-123
6mg/ml ampule solution for injection @ .01mg/kg
Placebo
6 mg/mlampule of solution for injection
placebo
6 mg/ml ampule solution for injection at .01mg/kg
Interventions
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ART-123
6mg/ml ampule solution for injection @ .01mg/kg
placebo
6 mg/ml ampule solution for injection at .01mg/kg
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects \< 18 years of age
* Known conditions that could confound the diagnosis of DIC due to sepsis
* Known conditions that increase the risk of bleeding
* Known medical condition associated with a hypercoagulable state
* Known or suspected severe liver disease
* History of solid organ (excluding uncomplicated kidney), bone marrow or stem cell transplantation
* Renal failure
18 Years
ALL
No
Sponsors
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Artisan Pharma, Inc.
INDUSTRY
Responsible Party
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Artisan Pharma, Inc
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Tuscon, Arizona, United States
Bakersfield, California, United States
Colton, California, United States
Loma Linda, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Rancho Mirage, California, United States
San Diego, California, United States
San Francisco, California, United States
Stanford, California, United States
Hartford, Connecticut, United States
Bay Pines, Florida, United States
Celebration, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Springfield, Illinois, United States
Kansas City, Kansas, United States
Topeka, Kansas, United States
Hazard, Kentucky, United States
Louisville, Kentucky, United States
Shreveport, Louisiana, United States
Springfield, Massachusetts, United States
Ann Arbor, Michigan, United States
Kalamazoo, Michigan, United States
Pontiac, Michigan, United States
Camden, New Jersey, United States
Englewood, New Jersey, United States
Newark, New Jersey, United States
Flushing, New York, United States
Durham, North Carolina, United States
Fayetteville, North Carolina, United States
Winston-Salem, North Carolina, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Kettering, Ohio, United States
Toledo, Ohio, United States
Danville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Columbia, South Carolina, United States
Knoxville, Tennessee, United States
Houston, Texas, United States
Lackland Air Force Base, Texas, United States
Edmonton, Alberta, Canada
Victoria, British Columbia, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Windsor, Ontario, Canada
Greenfield Park, Quebec, Canada
Kuala Pahang, , Malaysia
Lumpur, , Malaysia
Sarawak, , Malaysia
Chiang Mai, , Thailand
Nakhonratchasima, , Thailand
Countries
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Other Identifiers
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2-001
Identifier Type: -
Identifier Source: org_study_id
NCT01090115
Identifier Type: -
Identifier Source: nct_alias
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