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

Phase 2

Completed

• Conditions: Sepsis; Disseminated Intravascular Coagulation
• Interventions: Drug: placebo; Drug: ART-123

• Registration Number: NCT00487656
• Lead Sponsor: Artisan Pharma, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-06-15
• Study First Submitted QC: 2007-06-15
• Study First Posted: 2007-06-18
• Study Start: 2007-07
• Primary Completion: 2010-05
• Study Completion: 2010-08
• Status Verified: 2011-05
• Disposition First Submitted: 2011-05-06
• Disposition First Submitted QC: 2011-05-06
• Disposition First Posted: 2011-05-13
• Last Update Submitted: 2011-05-13
• Last Update Posted: 2011-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	6 mg/mlampule of solution for injection
ART-123	ART-123	6 mg/ml ampule solution for injection

Primary Outcome Measures

Name	Time	Method
28-Day All-cause mortality	28 day