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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Artisan Pharma, Inc.; University of South Alabama
• Collaborator: Artisian Pharmaceuticals

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