Clinical Trial

Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

Study acronym: RED-C-3131
Active, Not Recruiting Phase 3
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Record status
This record was last updated July 24, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.
Summary
Study RNLC3131 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 2021-09-28; most recent amendment 2025-07-21.
Status change: Completed → Active, Not Recruiting 2024-03-21
Status change: Recruiting → Completed 2024-03-13
Status change: Not Yet Recruiting → Recruiting 2022-04-07
Trial Details
NCT Number NCT05071716
Lead Sponsor Bausch Health Americas, Inc.
Conditions Hepatic Encephalopathy
Enrollment 524 participants
Start Date 2022-04-07
Primary Completion 2025-09 (estimated)
Study Completion 2025-09 (estimated)
Updated on ClinicalTrials.gov 2025-07-24