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

This study has been completed.

Sponsor:

Information provided by:

Artisan Pharma, Inc.

ClinicalTrials.gov Identifier:

NCT00487656

First received: June 15, 2007

Last updated: May 13, 2011

Last verified: May 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 15, 2007
Last Updated Date	May 13, 2011
Start Date ^ICMJE	July 2007
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 10, 2009)	28-Day All-cause mortality [ Time Frame: 28 day ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: June 15, 2007)	28-Day All-cause mortality
Change History	Complete list of historical versions of study NCT00487656 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular Coagulation
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Sepsis Disseminated Intravascular Coagulation
Intervention ^ICMJE	Drug: ART-123 6mg/ml ampule solution for injection @ .01mg/kg Drug: placebo 6 mg/ml ampule solution for injection at .01mg/kg
Study Arm (s)	Experimental: ART-123 6 mg/ml ampule solution for injection Intervention: Drug: ART-123 Placebo Comparator: Placebo 6 mg/mlampule of solution for injection Intervention: Drug: placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	750
Completion Date	August 2010
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada, Malaysia, Thailand

Administrative Information
NCT Number ^ICMJE	NCT00487656
Other Study ID Numbers ^ICMJE	2-001
Has Data Monitoring Committee	Yes
Responsible Party	Inder Kaul, Chief Medical Officer, Artisan Pharma, Inc
Study Sponsor ^ICMJE	Artisan Pharma, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Artisan Pharma, Inc.
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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