Clinical Trial

Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis

Study acronym: RED-C-3132
Active, Not Recruiting Phase 3
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Record status
This record was last updated September 10, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
Summary
Study RNLC3132 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2022-03-17; most recent amendment 2025-09-03.
Status change: Recruiting → Active, Not Recruiting 2024-05-07
Status change: Not Yet Recruiting → Recruiting 2022-08-16
Trial Details
NCT Number NCT05297448
Lead Sponsor Bausch Health Americas, Inc.
Conditions Hepatic Encephalopathy
Enrollment 466 participants
Start Date 2022-08-03
Primary Completion 2026-01 (estimated)
Study Completion 2026-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-10