Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular Coagulation
A Randomized, Double-Blind, Placebo-Controlled, Phase-2B Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects With Sepsis and Disseminated Intravascular Coagulation
1 other identifier
interventional
750
4 countries
62
Brief Summary
The purpose of this study is to see if ART-123 (recombinant human soluble thrombomodulin) decreases the number of people who die as a result of Disseminated Intravascular Coagulation (DIC) complication of sepsis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 sepsis
Started Jul 2007
Typical duration for phase_2 sepsis
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2007
CompletedFirst Posted
Study publicly available on registry
June 18, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedMay 18, 2011
May 1, 2011
2.8 years
June 15, 2007
May 13, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
28-Day All-cause mortality
28 day
Study Arms (2)
ART-123
EXPERIMENTAL6 mg/ml ampule solution for injection
Placebo
PLACEBO COMPARATOR6 mg/mlampule of solution for injection
Interventions
Eligibility Criteria
You may qualify if:
- Infection or suspected infection resulting in sepsis and DIC
You may not qualify if:
- Unable to provide informed consent, or lack of consent from an acceptable surrogate
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tuscon, Arizona, United States
Unknown Facility
Bakersfield, California, United States
Unknown Facility
Colton, California, United States
Unknown Facility
Loma Linda, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Rancho Mirage, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Stanford, California, United States
Unknown Facility
Hartford, Connecticut, United States
Unknown Facility
Bay Pines, Florida, United States
Unknown Facility
Celebration, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Springfield, Illinois, United States
Unknown Facility
Kansas City, Kansas, United States
Unknown Facility
Topeka, Kansas, United States
Unknown Facility
Hazard, Kentucky, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
Pontiac, Michigan, United States
Unknown Facility
Camden, New Jersey, United States
Unknown Facility
Englewood, New Jersey, United States
Unknown Facility
Newark, New Jersey, United States
Unknown Facility
Flushing, New York, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Fayetteville, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Akron, Ohio, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Kettering, Ohio, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Danville, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Columbia, South Carolina, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Lackland Air Force Base, Texas, United States
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
Kingston, Ontario, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Oshawa, Ontario, Canada
Unknown Facility
Ottawa, Ontario, Canada
Unknown Facility
Windsor, Ontario, Canada
Unknown Facility
Greenfield Park, Quebec, Canada
Unknown Facility
Kuala Pahang, Malaysia
Unknown Facility
Lumpur, Malaysia
Unknown Facility
Sarawak, Malaysia
Unknown Facility
Chiang Mai, Thailand
Unknown Facility
Nakhonratchasima, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 15, 2007
First Posted
June 18, 2007
Study Start
July 1, 2007
Primary Completion
May 1, 2010
Study Completion
August 1, 2010
Last Updated
May 18, 2011
Record last verified: 2011-05