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

NCT00487656 — Phase 2, Completed, 750 participants, Artisan Pharma, Inc.
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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

RegistryNCT00487656
StatusCompleted
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment750 (Actual)
SponsorArtisan Pharma, Inc. (Industry)
ConditionsSepsis, Disseminated Intravascular Coagulation
InterventionsART-123, placebo (Drug)
Datesstart 2007-07-01, primary completion 2010-05-01, completion 2010-08-01, first posted 2007-06-18, last updated 2011-05-18
Locations62 sites in United States, Canada, Malaysia, Thailand

Related Papers Related Patents Related Grants Related Experts
All trials for Sepsis All trials for Disseminated Intravascular Coagulation All trials of ART-123 All trials of placebo

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
ART-123ExperimentalDrug: ART-1236 mg/ml ampule solution for injection
PlaceboPlacebo comparatorDrug: placebo6 mg/mlampule of solution for injection
  • ART-123 (Drug): 6mg/ml ampule solution for injection @ .01mg/kg
  • placebo (Drug): 6 mg/ml ampule solution for injection at .01mg/kg

+Outcome measures

Primary outcomes

  • 28-Day All-cause mortality [28 day]

+Eligibility

Sex: All, ages: 18 Years to any

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)

FacilityCityCountryStatus
Birmingham, AlabamaUnited States
Phoenix, ArizonaUnited States
Tuscon, ArizonaUnited States
Bakersfield, CaliforniaUnited States
Colton, CaliforniaUnited States
Loma Linda, CaliforniaUnited States
Long Beach, CaliforniaUnited States
Los Angeles, CaliforniaUnited States
Rancho Mirage, CaliforniaUnited States
San Diego, CaliforniaUnited States
San Francisco, CaliforniaUnited States
Stanford, CaliforniaUnited States
Hartford, ConnecticutUnited States
Bay Pines, FloridaUnited States
Celebration, FloridaUnited States
Jacksonville, FloridaUnited States
Miami, FloridaUnited States
Orlando, FloridaUnited States
Atlanta, GeorgiaUnited States
Augusta, GeorgiaUnited States
Springfield, IllinoisUnited States
Kansas City, KansasUnited States
Topeka, KansasUnited States
Hazard, KentuckyUnited States
Louisville, KentuckyUnited States
Shreveport, LouisianaUnited States
Springfield, MassachusettsUnited States
Ann Arbor, MichiganUnited States
Kalamazoo, MichiganUnited States
Pontiac, MichiganUnited States
Camden, New JerseyUnited States
Englewood, New JerseyUnited States
Newark, New JerseyUnited States
Flushing, New YorkUnited States
Durham, North CarolinaUnited States
Fayetteville, North CarolinaUnited States
Winston-Salem, North CarolinaUnited States
Akron, OhioUnited States
Cincinnati, OhioUnited States
Cleveland, OhioUnited States
Columbus, OhioUnited States
Kettering, OhioUnited States
Toledo, OhioUnited States
Danville, PennsylvaniaUnited States
Pittsburgh, PennsylvaniaUnited States
Columbia, South CarolinaUnited States
Knoxville, TennesseeUnited States
Houston, TexasUnited States
Lackland Air Force Base, TexasUnited States
Edmonton, AlbertaCanada
Victoria, British ColumbiaCanada
Kingston, OntarioCanada
London, OntarioCanada
Oshawa, OntarioCanada
Ottawa, OntarioCanada
Windsor, OntarioCanada
Greenfield Park, QuebecCanada
Kuala PahangMalaysia
LumpurMalaysia
SarawakMalaysia
Chiang MaiThailand
NakhonratchasimaThailand