Active — Not RecruitingPhase 3

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

United States466 participantsStarted 2022-08-03

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

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

Timeframe: 72 weeks

Trial details

NCT IDNCT05297448

SponsorBausch Health Americas, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01

View on ClinicalTrials.gov More Hepatic Encephalopathy trials