RNLC3131 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RIFAXIMIN SOLUBLE SOLID DISPERSION (SSD) TABLETS FOR THE DELAY OF ENCEPHALOPATHY DECOMPENSATION IN CIRRHOSIS (RED-C)

NCT05071716

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RIFAXIMIN SOLUBLE SOLID DISPERSION (SSD) TABLETS FOR THE DELAY OF ENCEPHALOPATHY DECOMPENSATION IN CIRRHOSIS (RED-C)

Principal Investigator

Sponsor

Salix Pharmaceuticals, Inc.

Salix Pharmaceuticals, Inc. an affiliate of Bausch Health US, LLC (the Sponsor) is running a research study to see if an investigational drug, named Rifaximin SSD-40IR given twice daily will help to delay the first episode of overt hepatic encephalopathy (OHE) requiring hospitalization, in patients with liver cirrhosis and how safe it is to use in people. Subjects will be asked to take part in this research study because they have liver cirrhosis and may have a risk of developing hepatic encephalopathy.