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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00487656
Recruitment Status : Completed
First Posted : June 18, 2007
Last Update Posted : May 18, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Sepsis Disseminated Intravascular Coagulation Drug: ART-123 Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2007
Primary Completion Date : May 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 28-Day All-cause mortality [ Time Frame: 28 day ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487656


  Show 62 Study Locations
Sponsors and Collaborators
Artisan Pharma, Inc.
More Information

Responsible Party: Inder Kaul, Chief Medical Officer, Artisan Pharma, Inc
ClinicalTrials.gov Identifier: NCT00487656     History of Changes
Obsolete Identifiers: NCT01090115
Other Study ID Numbers: 2-001
First Posted: June 18, 2007    Key Record Dates
Last Update Posted: May 18, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Sepsis
Toxemia
Disseminated Intravascular Coagulation
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia
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