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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
524
Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily
Placebo Twice Daily
Time to first event of overt hepatic encephalopathy requiring medical intervention in hospital/ER/ED/clinic or death.
Time frame: 72 weeks
Time to first Conn score ≥ 2 or confirmed OHE requiring medical intervention in hospital/ER/ED/ clinic or death
Time frame: 72 weeks
Time to all-cause hospitalization
Time frame: 72 weeks
Time to first event of OHE that requires hospitalization, or all-cause death
Time frame: 72 weeks
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