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The Safety And Efficacy of ART-123 in Subjects With Sepsis and Coagulopathy

NCT03517501 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-09-13

No results posted yet for this study

Summary

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

Conditions

  • Sepsis and 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 Comparator - 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, MD · Asahi Kasei Pharma America

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2022-04-30
Completion
2023-05-31
FDA Drug
Yes

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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 NCT03517501 on ClinicalTrials.gov