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

This study has been completed.
Sponsor:
Information provided by:
Artisan Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00487656
First received: June 15, 2007
Last updated: May 13, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Sepsis
Disseminated Intravascular Coagulation
Drug: ART-123
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Artisan Pharma, Inc.:

Primary Outcome Measures:
  • 28-Day All-cause mortality [ Time Frame: 28 day ] [ Designated as safety issue: Yes ]

Enrollment: 750
Study Start Date: July 2007
Study Completion Date: August 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487656

  Hide Study Locations
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
Malaysia
Lumpur, Malaysia
Pahang, Malaysia
Sarawak, Malaysia
Thailand
Chiangmai, Thailand
Nakhonratchasima, Thailand
Sponsors and Collaborators
Artisan Pharma, Inc.
  More Information

No publications provided

Responsible Party: Inder Kaul, Chief Medical Officer, Artisan Pharma, Inc
ClinicalTrials.gov Identifier: NCT00487656     History of Changes
Other Study ID Numbers: 2-001
Study First Received: June 15, 2007
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Administration
Argentina: Ministry of Health

Additional relevant MeSH terms:
Sepsis
Toxemia
Disseminated Intravascular Coagulation
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia

ClinicalTrials.gov processed this record on September 22, 2014