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

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.

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)