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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
  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 2

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:

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 May 21, 2013