At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 816 enrolled
Drug / intervention
ART-123 +1 moredrug
Likely dose
ART-123 0.06 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating ART-123 and Placebo for Severe Sepsis and Coagulopathy. Completed, enrolled 816 participants across 161 sites in 24 countries.
Detailed Summary
The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Sepsis, Coagulopathy
CountriesArgentina, 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, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartOct 2012
Primary CompletionApr 2018
Study CompletionFeb 2019
TodayJul 2026
First PostedMay 15, 2012
Enrollment StartOct 29, 2012
Primary CompletionApr 5, 2018
Study CompletionFeb 28, 2019
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 14.1 years ago
Interventions
ART-123drug
Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
Placebodrug
Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days.