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

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

NCT00487656

2-001

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

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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