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-3132)

NCT05297448 Phase 3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Bausch Health Americas, Inc.
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	466
Start date	2022-08-03
Completion	2026-01

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, Belgium, Bulgaria, Canada, France, Germany, Hungary, India, Italy, Mongolia, New Zealand, Poland, Puerto Rico, South Korea, Spain, United Kingdom