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

A

Artisan Pharma

Status and phase

Completed
Phase 2

Conditions

Disseminated Intravascular Coagulation
Sepsis

Treatments

Drug: placebo
Drug: ART-123

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

750 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

750 participants in 2 patient groups, including a placebo group

ART-123
Experimental group
Description:
6 mg/ml ampule solution for injection
Treatment:
Drug: ART-123
Placebo
Placebo Comparator group
Description:
6 mg/mlampule of solution for injection
Treatment:
Drug: placebo

Trial contacts and locations

62

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Data sourced from clinicaltrials.gov

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