Trial | NCT00487656  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    750
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.
Study Started
Jul 31
2007
Primary Completion
May 31
2010
Study Completion
Aug 31
2010
Last Update
May 18
2011
Estimate

Drug ART-123

6mg/ml ampule solution for injection @ .01mg/kg

Drug placebo

6 mg/ml ampule solution for injection at .01mg/kg

ART-123 Experimental

6 mg/ml ampule solution for injection

Placebo Placebo Comparator

6 mg/mlampule of solution for injection

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
No Results Posted