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

NCT00487656 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2011-05-18

No results posted yet for this study

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.

Conditions

  • Sepsis
  • Disseminated Intravascular Coagulation

Interventions

DRUG

ART-123

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

DRUG

placebo

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

Sponsors & Collaborators

  • Artisan Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-05-31
Completion
2010-08-31

Countries

  • United States
  • Canada
  • Malaysia
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00487656 on ClinicalTrials.gov