clinical trial · NCT05071716
Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
Bausch Health Americas, Inc.·phase3·active not recruiting·n = 524
Hepatic EncephalopathyRifaximin SSDPlacebo
brief 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.
started
Apr 7, 2022
primary completion
Sep 1, 2025
completion
Sep 1, 2025
last updated
Jul 24, 2025
official 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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol