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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487656
• Other study ID #: 2-001
• Status: Completed
• Phase: Phase 2
• First received: June 15, 2007
• Last updated: May 13, 2011
• Start date: July 2007
• Est. completion date: August 2010

Study information

• Verified date: May 2011
• Source: Artisan Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Therapeutic Goods AdministrationArgentina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: August 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disseminated Intravascular Coagulation
• Sepsis

Intervention

Drug:
• ART-123
6mg/ml ampule solution for injection @ .01mg/kg
• placebo
6 mg/ml ampule solution for injection at .01mg/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Artisan Pharma, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Malaysia,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-Day All-cause mortality		28 day	Yes