drugset / Trial / NCT03517501
The Safety And Efficacy of ART-123 in Subjects With Sepsis and Coagulopathy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | thrombomodulin alfa | Protein / enzyme biologic | 0.06 mg/kg | — |
| Comparator | thrombomodulin alfa | Protein / enzyme biologic | 6 mg | — |