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

Primary Purpose

Sepsis, Disseminated Intravascular Coagulation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ART-123
placebo
Sponsored by
Artisan Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ART-123

Placebo

Arm Description

6 mg/ml ampule solution for injection

6 mg/mlampule of solution for injection

Outcomes

Primary Outcome Measures

28-Day All-cause mortality

Secondary Outcome Measures

Full Information

First Posted
June 15, 2007
Last Updated
May 13, 2011
Sponsor
Artisan Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00487656
Brief Title
Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular Coagulation
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 Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Artisan Pharma, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Disseminated Intravascular Coagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
750 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ART-123
Arm Type
Experimental
Arm Description
6 mg/ml ampule solution for injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
6 mg/mlampule of solution for injection
Intervention Type
Drug
Intervention Name(s)
ART-123
Intervention Description
6mg/ml ampule solution for injection @ .01mg/kg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
6 mg/ml ampule solution for injection at .01mg/kg
Primary Outcome Measure Information:
Title
28-Day All-cause mortality
Time Frame
28 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Birmingham
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Alabama
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United States
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Phoenix
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United States
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Tuscon
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Bakersfield
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Colton
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Loma Linda
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Long Beach
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Los Angeles
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Rancho Mirage
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San Diego
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San Francisco
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Stanford
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Hartford
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Bay Pines
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Celebration
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Jacksonville
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Miami
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Orlando
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Atlanta
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Augusta
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Springfield
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Illinois
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Kansas City
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Topeka
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Hazard
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Louisville
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Shreveport
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Springfield
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Ann Arbor
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Kalamazoo
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Pontiac
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Camden
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Englewood
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Newark
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Flushing
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New York
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Durham
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Fayetteville
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Winston - Salem
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Akron
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Cincinnati
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Cleveland
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Columbus
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Kettering
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Toledo
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Danville
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Pittsburgh
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Columbia
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South Carolina
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Knoxville
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Houston
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Lackland AFB
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Edmonton
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Victoria
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Canada
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Kingston
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London
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Oshawa
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Ottawa
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Windsor
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Greenfield Park
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Quebec
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Lumpur
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Malaysia
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Pahang
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Malaysia
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Sarawak
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Malaysia
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Chiangmai
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Thailand
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Nakhonratchasima
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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