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Active, Not Recruiting

NCT Number: NCT05297448

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bausch Site 709, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Diagnosis of liver cirrhosis with medically controlled ascites (>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past).
  • Conn (West Haven Criteria) score of < 2.
  • Mini-Mental State Examination (MMSE) score > 24 at screening.
  • ≥ 18 and ≤ 85 years of age.

Key Exclusion Criteria:

  • Active COVID-19 that is unresolved
  • History of SBP
  • History of EVB or AKI-HRS within 6 months
  • History of OHE episode (Conn score ≥ 2)

Treatment and study plan

Rifaximin SSD

Drug

Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily

Placebo

Drug

Placebo Twice Daily

Primary outcomes

  1. Time to first event of overt hepatic encephalopathy requiring medical intervention in hospital/ER/ED/clinic or death.

    Time frame: 72 weeks

Secondary outcomes

  1. Time to first Conn score ≥ 2 or confirmed OHE requiring medical intervention in hospital/ER/ED/clinic or death

    Time frame: 72 weeks

  2. Time to all-cause hospitalization

    Time frame: 72 weeks

  3. Time to first event of OHE that requires hospitalization, or all-cause death

    Time frame: 72 weeks

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

Acronym: RED-C-3132

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 28, 2022
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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