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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00487656
Other study ID # 2-001
Secondary ID
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
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