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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00487656
Recruitment Status : Completed
First Posted : June 18, 2007
Last Update Posted : May 18, 2011
Information provided by:
Artisan Pharma, Inc.

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.

Condition or disease Intervention/treatment Phase
Sepsis Disseminated Intravascular Coagulation Drug: ART-123 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ART-123
6 mg/ml ampule solution for injection
Drug: ART-123
6mg/ml ampule solution for injection @ .01mg/kg
Placebo Comparator: Placebo
6 mg/mlampule of solution for injection
Drug: placebo
6 mg/ml ampule solution for injection at .01mg/kg

Primary Outcome Measures :
  1. 28-Day All-cause mortality [ Time Frame: 28 day ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Infection or suspected infection resulting in sepsis and DIC

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00487656

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Tuscon, Arizona, United States
United States, California
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
United States, Connecticut
Hartford, Connecticut, United States
United States, Florida
Bay Pines, Florida, United States
Celebration, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
United States, Illinois
Springfield, Illinois, United States
United States, Kansas
Kansas City, Kansas, United States
Topeka, Kansas, United States
United States, Kentucky
Hazard, Kentucky, United States
Louisville, Kentucky, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Massachusetts
Springfield, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Kalamazoo, Michigan, United States
Pontiac, Michigan, United States
United States, New Jersey
Camden, New Jersey, United States
Englewood, New Jersey, United States
Newark, New Jersey, United States
United States, New York
Flushing, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Fayetteville, North Carolina, United States
Winston - Salem, North Carolina, United States
United States, Ohio
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Kettering, Ohio, United States
Toledo, Ohio, United States
United States, Pennsylvania
Danville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Columbia, South Carolina, United States
United States, Tennessee
Knoxville, Tennessee, United States
United States, Texas
Houston, Texas, United States
Lackland AFB, Texas, United States
Canada, Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
Victoria, British Columbia, Canada
Canada, Ontario
Kingston, Ontario, Canada
London, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Windsor, Ontario, Canada
Canada, Quebec
Greenfield Park, Quebec, Canada
Lumpur, Malaysia
Pahang, Malaysia
Sarawak, Malaysia
Chiangmai, Thailand
Nakhonratchasima, Thailand
Sponsors and Collaborators
Artisan Pharma, Inc.

Responsible Party: Inder Kaul, Chief Medical Officer, Artisan Pharma, Inc Identifier: NCT00487656     History of Changes
Obsolete Identifiers: NCT01090115
Other Study ID Numbers: 2-001
First Posted: June 18, 2007    Key Record Dates
Last Update Posted: May 18, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Disseminated Intravascular Coagulation
Systemic Inflammatory Response Syndrome
Pathologic Processes
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Pharmaceutical Solutions