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

June 15, 2007
May 13, 2011
July 2007
May 2010   (final data collection date for primary outcome measure)
28-Day All-cause mortality [ Time Frame: 28 day ] [ Designated as safety issue: Yes ]
28-Day All-cause mortality
Complete list of historical versions of study NCT00487656 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Sepsis
  • Disseminated Intravascular Coagulation
  • Drug: ART-123
    6mg/ml ampule solution for injection @ .01mg/kg
  • Drug: placebo
    6 mg/ml ampule solution for injection at .01mg/kg
  • Experimental: ART-123
    6 mg/ml ampule solution for injection
    Intervention: Drug: ART-123
  • Placebo Comparator: Placebo
    6 mg/mlampule of solution for injection
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
August 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Malaysia,   Thailand
 
NCT00487656
2-001
Yes
Inder Kaul, Chief Medical Officer, Artisan Pharma, Inc
Artisan Pharma, Inc.
Not Provided
Not Provided
Artisan Pharma, Inc.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP