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

Phase 3 Active not recruiting 524 enrolled Bausch Health Americas, Inc.

RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start: 2022-04-07
Primary completion: 2025-09
Completion: 2025-09

Publications

Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rifaximin	Other / unclassified	40 mg	—

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

Summary

Timeline

Publications

Drugs

Indications