NCT01598831

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

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects With Severe Sepsis and Coagulopathy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 816 (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

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

Timeline

• Start date: 2012-10-29
• Primary completion: 2018-04-05
• Completion: 2019-02-28
• First posted: 2012-05-15
• Last updated: 2020-04-21
• Results posted: 2020-04-21

Locations

161 sites across 24 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