NCT05071716 (RNLC3131).

Study name	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
Methods	Randomised, double‐blind, multicentre, phase 3 primary prevention trial
Participants	Inclusion criteria (target sample size = 466) People with liver cirrhosis and medically controlled ascites (> 30 days) not requiring therapeutic paracentesis Child‐Pugh B without overt hepatic encephalopathy (West Haven < 2) and a MELD‐Na score of < 15 at first visit No previous documented episode of overt hepatic encephalopathy, with no history of rifaximin or lactulose use
Interventions	Intervention: rifaximin soluble solid dispersion immediate release 40 mg twice daily Control: placebo twice daily
Outcomes	Time to first event of overt hepatic encephalopathy requiring hospitalisation Time to all‐cause hospitalisation Assessment period: 72 weeks
Starting date	7 April 2022
Contact information	John Lahey (Bausch Health), john.lahey@bauschhealth.com, 908‐541‐8631
Notes	Estimated primary completion date: January 2025 Estimated study completion date: January 2025 Data from this study, when completed, could be included in future versions of this review.