Who is sponsoring RED-C-3131?

RED-C-3131 is sponsored by Bausch Health Americas, Inc..

What condition does RED-C-3131 study?

RED-C-3131 studies Hepatic Encephalopathy.

What drugs are being tested in RED-C-3131?

Interventions: Rifaximin SSD, Placebo.

What is the status of RED-C-3131?

RED-C-3131 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2025-07-21 · How we verify

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 (RED-C-3131)

NCT05071716 Phase 3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Bausch Health Americas, Inc.
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	524
Start date	2022-04-07
Completion	2025-09

Conditions

Hepatic Encephalopathy

Interventions

Rifaximin SSD
Placebo

Primary outcomes

Time to first event of overt hepatic encephalopathy requiring medical intervention in hospital/ER/ED/clinic or death. — 72 weeks

Countries

United States, Australia, Canada, Puerto Rico