NCT03517501

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

Scarlet-2: A Randomized, Double-Blind,Placebo-Controlled, Phase 3 Study to Assess The Safety And Efficacy of ART-123 in Subjects With Sepsis and Coagulopathy

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Asahi Kasei Pharma America Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Study is to evaluate if ART-123 given to patients who have severe sepsis complicated by at least one organ dysfunction and coagulopathy can decrease mortality

Conditions

• Sepsis and Coagulopathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-04-01
• Completion: 2023-05-01
• First posted: 2018-05-07
• Last updated: 2019-09-13

Regulatory

• FDA-regulated drug study