At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 300 enrolled
Drug / intervention
Terlipressin +1 moredrug
Likely dose
Not stated in 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 Efficacy and Safety of Terlipressin in Subjects With Hepatorenal Syndrome Type 1 (The CONFIRM Study)
In Brief
A Phase 3 clinical trial evaluating Terlipressin and Placebo for Hepatorenal Syndrome. Completed, enrolled 300 participants across 64 sites in 2 countries.
Detailed Summary
This study is to treat adult patients with hepatorenal syndrome (HRS) Type 1. Out of every three participants, two will receive terlipressin and one will receive placebo. Assignments will be made randomly.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatorenal Syndrome
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartJul 2016
Primary CompletionJul 2019
TodayJul 2026
First PostedMay 12, 2016
Enrollment StartJul 13, 2016
Primary CompletionJul 24, 2019
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 10.1 years ago
Interventions
Terlipressindrug
Terlipressin solution for injection
Placeboother
Matching placebo solution for injection