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

This study is currently recruiting participants.

Verified by Artisan Pharma, Inc., November 2007

Sponsored by:	Artisan Pharma, Inc.
Information provided by:	Artisan Pharma, Inc.
ClinicalTrials.gov Identifier:	NCT00487656

Purpose

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.

Condition	Intervention	Phase
Sepsis Disseminated Intravascular Coagulation	Drug: ART-123 (recombinant human soluble thrombomodulin)	Phase II

Genetics Home Reference related topics: factor V Leiden thrombophilia hemophilia

MedlinePlus related topics: Sepsis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	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

Further study details as provided by Artisan Pharma, Inc.:

Primary Outcome Measures:

28-Day All-cause mortality

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487656

Contacts

Contact: David Gelmont, MD

781-419-1930

dgelmont@artisanpharma.net

Show 63 Study Locations

Sponsors and Collaborators

Artisan Pharma, Inc.

More Information

Study ID Numbers:	2-001
Study First Received:	June 15, 2007
Last Updated:	November 12, 2007
ClinicalTrials.gov Identifier:	NCT00487656
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Australia: Therapeutic Goods Administration

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Disseminated Intravascular Coagulation
Sepsis
Hemorrhagic Disorders
Hematologic Diseases

Thrombophilia
Blood Coagulation Disorders
Hemostatic Disorders
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009