NCT00487656

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 750 (actual)
• Sponsor: Artisan Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	ART-123	6mg/ml ampule solution for injection @ .01mg/kg
DRUG	placebo	6 mg/ml ampule solution for injection at .01mg/kg

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-05-01
• Completion: 2010-08-01
• First posted: 2007-06-18
• Last updated: 2011-05-18

Locations

62 sites across 4 countries: United States, Canada, Malaysia, Thailand