Overview

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.
Treatments:
Pharmaceutical Solutions
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