drugset / Trial / NCT05297448

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

NCT05297448

Phase 3 Active not recruiting 466 enrolled Bausch Health Americas, Inc.
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2022-08-03
Primary completion
2026-01
Completion
2026-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Rifaximin Other / unclassified 40 mg