Clinical trial NCT00487656: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sepsis
Disseminated Intravascular Coagulation
Lead sponsor: Artisan Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2007-06-18
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 28-Day All-cause mortality
timeFrame: 28 day
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tuscon
country: United States
state: Arizona
city: Bakersfield
country: United States
state: California
city: Colton
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Stanford
country: United States
state: California
city: Hartford
country: United States
state: Connecticut
city: Bay Pines
country: United States
state: Florida
city: Celebration
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Springfield
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Topeka
country: United States
state: Kansas
city: Hazard
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Shreveport
country: United States
state: Louisiana
city: Springfield
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Pontiac
country: United States
state: Michigan
city: Camden
country: United States
state: New Jersey
city: Englewood
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Flushing
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Fayetteville
country: United States
state: North Carolina
city: Winston - Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Danville
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Lackland AFB
country: United States
state: Texas
city: Edmonton
country: Canada
state: Alberta
city: Victoria
country: Canada
state: British Columbia
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Greenfield Park
country: Canada
state: Quebec
city: Lumpur
country: Malaysia
city: Pahang
country: Malaysia
city: Sarawak
country: Malaysia
city: Chiangmai
country: Thailand
city: Nakhonratchasima
country: Thailand
Study officials:
References: