Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular Coagulation

Completed · Phase 2 · Has a placebo group

Conditions studied: Sepsis, Disseminated Intravascular Coagulation

In brief

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.

Key facts

Study ID

NCT00487656

Run by

Artisan Pharma, Inc.

People needed

750

Starts

2007-07-01

Expected to finish

2010-08-01

Last updated by the study team

2011-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Tuscon, Arizona, United States
• Study site — Bakersfield, California, United States
• Study site — Colton, California, United States
• Study site — Loma Linda, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Stanford, California, United States
• Study site — Hartford, Connecticut, United States
• Study site — Bay Pines, Florida, United States
• Study site — Celebration, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Springfield, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — Topeka, Kansas, United States
• Study site — Hazard, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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