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

This study has been completed.

First Received on June 15, 2007. Last Updated on May 13, 2011 History of Changes

Sponsor:	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 Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: factor V Leiden thrombophilia hemophilia prothrombin thrombophilia

MedlinePlus related topics: Sepsis

U.S. FDA Resources

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

Primary Outcome Measures:

28-Day All-cause mortality [ Time Frame: 28 day ] [ Designated as safety issue: Yes ]

Enrollment:	750
Study Start Date:	July 2007
Study Completion Date:	August 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ART-123 6 mg/ml ampule solution for injection	Drug: ART-123 6mg/ml ampule solution for injection @ .01mg/kg
Placebo Comparator: Placebo 6 mg/mlampule of solution for injection	Drug: placebo 6 mg/ml ampule solution for injection at .01mg/kg

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

Show 62 Study Locations

Sponsors and Collaborators

Artisan Pharma, Inc.

More Information

No publications provided

Responsible Party:	Inder Kaul, Chief Medical Officer, Artisan Pharma, Inc
ClinicalTrials.gov Identifier:	NCT00487656 History of Changes
Other Study ID Numbers:	2-001
Study First Received:	June 15, 2007
Last Updated:	May 13, 2011
Health Authority:	United States: Food and Drug Administration; Australia: Therapeutic Goods Administration; Argentina: Ministry of Health

Additional relevant MeSH terms:

Disseminated Intravascular Coagulation
Sepsis
Toxemia
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders

Thrombophilia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012