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

Condition(s) studied

Investigational drug(s) / intervention(s)

Rifaximin SSD: Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily

Placebo: Placebo Twice Daily

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (150)

+ 110 more sites — see the full list on the official registry below.

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