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

Study acronym: RED-C-3131
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary endpoint revised Secondary endpoints revised (3)v10 Show 1 more changeShow less
    • Secondary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

  2. Primary and study completion dates: Dec 31, 2023 to Sep 2025 Trial status: Completed to Active, Not Recruitingv9 Show 1 more changeShow less
    • Trial status: Completed to Active, Not Recruiting
  3. Trial status: Recruiting to Completed Enrollment target: estimated 466 to confirmed 524 · Study sites: 165 to 150 · Primary and study completion dates changed from estimate of Jan 2025 to Dec 31, 2023v8 Show 3 more changesShow less
    • Enrollment target: estimated 466 to confirmed 524
    • Study sites: 165 to 150
    • Primary and study completion dates changed from estimate of Jan 2025 to Dec 31, 2023
  4. Study sites: 99 to 165v7
  5. Study sites: 98 to 99v6
Show 4 earlier versionsHide 4 earlier versions
  1. Eligibility criteria shortened, about 21 words Secondary endpoints: 1 to 3 · Study sites revised (98)v5 Show 2 more changesShow less
    • Secondary endpoints: 1 to 3
    • Study sites revised (98)

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 1 to 98 Eligibility criteria shortened, about 743 wordsv4 Show 1 more changeShow less
    • Eligibility criteria shortened, about 743 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Apr 2022 to Apr 7, 2022v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2022 to Apr 7, 2022
  4. Start date: Oct 2021 to Apr 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05071716
Lead Sponsor Bausch Health Americas, Inc.
Conditions Hepatic Encephalopathy
Enrollment 524 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov