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

May 13, 2011 updated by: Artisan Pharma, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

750

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Victoria, British Columbia, Canada
    • Ontario
      • Kingston, Ontario, Canada
      • London, Ontario, Canada
      • Oshawa, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Windsor, Ontario, Canada
    • Quebec
      • Greenfield Park, Quebec, Canada
  • Malaysia
      • Lumpur, Malaysia
      • Pahang, Malaysia
      • Sarawak, Malaysia
  • Thailand
      • Chiangmai, Thailand
      • Nakhonratchasima, Thailand
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tuscon, Arizona, United States
    • California
      • Bakersfield, California, United States
      • Colton, California, United States
      • Loma Linda, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Rancho Mirage, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
      • Stanford, California, United States
    • Connecticut
      • Hartford, Connecticut, United States
    • Florida
      • Bay Pines, Florida, United States
      • Celebration, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Augusta, Georgia, United States
    • Illinois
      • Springfield, Illinois, United States
    • Kansas
      • Kansas City, Kansas, United States
      • Topeka, Kansas, United States
    • Kentucky
      • Hazard, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Kalamazoo, Michigan, United States
      • Pontiac, Michigan, United States
    • New Jersey
      • Camden, New Jersey, United States
      • Englewood, New Jersey, United States
      • Newark, New Jersey, United States
    • New York
      • Flushing, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Fayetteville, North Carolina, United States
      • Winston - Salem, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Kettering, Ohio, United States
      • Toledo, Ohio, United States
    • Pennsylvania
      • Danville, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Tennessee
      • Knoxville, Tennessee, United States
    • Texas
      • Houston, Texas, United States
      • Lackland AFB, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
28-Day All-cause mortality
Time Frame: 28 day
28 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Artisan Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

June 15, 2007

First Submitted That Met QC Criteria

June 15, 2007

First Posted (ESTIMATE)

June 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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