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Clinical Trials in Australia / NCT05071716
Active, not recruiting Phase 3

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

NCT05071716 · tracked via the Priya Life Science Australia tracker
Sponsor
Bausch Health Americas, Inc
Phase
Phase 3
Started
2022-04-07
Last updated
2025-07-24

Condition(s) studied

Hepatic Encephalopathy

Investigational drug(s) / intervention(s)

Rifaximin SSD →Placebo

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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Key Inclusion Criteria: * Diagnosis of liver cirrhosis with medically controlled ascites (\>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past). * Conn (West Haven Criteria) score of \< 2. * Mini-Mental State Examination (MMSE) score \> 24 at screening. * ≥ 18 and ≤ 85 years of age. Key Exclusion Criteria: * Active COVID-19 that is unresolved * History of SBP * History of EVB or AKI-HRS within 6 months * History of OHE episode (Conn score ≥ 2)

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)

FacilityCityRegionStatus
Bausch Site 182 Dothan Alabama
Bausch Site 129 Chandler Arizona
Bausch Site 103 Peoria Arizona
Bausch Site 180 Phoenix Arizona
Bausch Site 153 Phoenix Arizona
Bausch Site 248 Tempe Arizona
Bausch Site 222 Tucson Arizona
Bausch Site 150 Little Rock Arkansas
Bausch Site 164 Bakersfield California
Bausch Site 196 Chula Vista California
Bausch Site 226 Chula Vista California
Bausch Site 174 Escondido California
Bausch Site 163 Fresno California
Bausch Site 242 Garden Grove California
Bausch Site 115 La Jolla California
Bausch Site 141 Lancaster California
Bausch Site 140 Los Angeles California
Bausch Site 189 Los Angeles California
Bausch Site 227 Orange California
Bausch Site 199 Pasadena California
Bausch Site 119 Redwood City California
Bausch Site 102 Rialto California
Bausch Site 177 San Diego California
Bausch Site 171 San Francisco California
Bausch Site 214 San Jose California
Bausch Site 183 Upland California
Bausch Site 143 Englewood Colorado
Bausch Site 212 Littleton Colorado
Bausch Site 151 Bristol Connecticut
Bausch Site 220 Bradenton Florida
Bausch Site 257 Cape Coral Florida
Bausch Site 197 Cutler Bay Florida
Bausch Site 249 Fort Myers Florida
Bausch Site 173 Hialeah Florida
Bausch Site 238 Hialeah Gardens Florida
Bausch Site 235 Hollywood Florida
Bausch Site 211 Homestead Florida
Bausch Site 139 Inverness Florida
Bausch Site 138 Jacksonville Florida
Bausch Site 241 Lakewood Rch Florida

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

More Bausch Health Americas, Inc. trials in Australia

Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis Active, not recruiting

Other trials for the same condition

Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05071716 on ClinicalTrials.gov ↗ ← All trials in Australia