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

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: Sepsis; Disseminated Intravascular Coagulation
• Intervention / Treatment: Drug: ART-123; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 750
• Phase: Phase 2

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	28 day

Collaborators and Investigators

• Sponsor: Artisan Pharma, Inc.

Study record dates

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: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Hemorrhagic Disorders; Blood Coagulation Disorders; Thrombophilia; Sepsis; Toxemia; Disseminated Intravascular Coagulation
• Other Study ID Numbers: 2-001