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Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular Coagulation | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT00487656•Artisan Pharma, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (62)

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Tuscon, Arizona, United States

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

Key Dates

Start Date

July 1, 2007

Primary Completion Date

May 1, 2010

Completion Date

August 1, 2010

Last Updated

May 18, 2011

Enrollment

750

ACTUAL participants

Conditions

SepsisDisseminated Intravascular Coagulation

Interventions

ART-123

DRUG

placebo

DRUG

Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm

NCT04850456

Critical IllnessSepsis, Severe

View study

RECRUITING

A Multi-Center Data System and Collaborative Network in China for Severe Infection and Sepsis Children

NCT04955210

Critical IllnessSevere Sepsis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm

A Multi-Center Data System and Collaborative Network in China for Severe Infection and Sepsis Children

Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit

African Survey on Sepsis Knowledge (ASK)