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Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy

NCT01598831 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 816

Last updated 2020-04-21

Study results available
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Summary

The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.

Conditions

  • Severe Sepsis
  • Coagulopathy

Interventions

DRUG

ART-123

Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days

DRUG

Placebo

Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days.

Sponsors & Collaborators

  • Asahi Kasei Pharma America Corporation

    lead INDUSTRY

Principal Investigators

  • David Fineberg, M.D. · Asahi Kasei Pharma America Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-29
Primary Completion
2018-04-05
Completion
2019-02-28

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Netherlands
  • New Zealand
  • Peru
  • Russia
  • Serbia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01598831 on ClinicalTrials.gov