drugset / Trial / NCT03517501

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

NCT03517501 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2019-07
Primary completion
2022-04
Completion
2023-05

Outcome

Outcome not reported

Stopped: “Sponsor will amend study design by incorporating reconfirmation of coagulopathy following discussion with FDA regarding findings from SCARLET1 study.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator thrombomodulin alfa Protein / enzyme biologic 0.06 mg/kg —
Comparator thrombomodulin alfa Protein / enzyme biologic 6 mg —