At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 196 enrolled
Drug / intervention
Terlipressin +1 moredrug
Likely dose
Terlipressin 6 mLfrom 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 Multi-Center, Randomized, Placebo-controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin® (Terlipressin) (The REVERSE Study)
In Brief
A Phase 3 clinical trial evaluating Terlipressin and Placebo for Hepatorenal Syndrome. Completed, enrolled 196 participants across 73 sites in 2 countries.
Detailed Summary
This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatorenal Syndrome
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartOct 2010
Primary CompletionFeb 2013
Study CompletionMay 2013
TodayJul 2026
First PostedJun 14, 2010
Enrollment StartOct 11, 2010
Primary CompletionFeb 1, 2013
Study CompletionMay 10, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.1 years ago
Interventions
Terlipressindrug
Each 6 mL vial contains 1 mg lyophilized terlipressin acetate and 10 mg mannitol in sterile 0.9% sodium chloride solution.
Placebodrug
11 mg mannitol reconstituted with 5 ml of sterile 0.9% sodium chloride solution.