NCT05071716

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 524 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	Rifaximin SSD	Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily
DRUG	Placebo	Placebo Twice Daily

Timeline

• Start date: 2022-04-07
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2021-10-08
• Last updated: 2025-07-24

Locations

150 sites across 4 countries: United States, Australia, Canada, Puerto Rico

Regulatory

• FDA-regulated drug study