Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Hepatic Encephalopathy
In brief
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.
Key facts
- Study ID
- NCT05071716
- Run by
- Bausch Health Americas, Inc.
- People needed
- 524
- Starts
- 2022-04-07
- Expected to finish
- 2025-09-01
- Last updated by the study team
- 2025-07-24
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Bausch Site 129 — Chandler, Arizona, United States
- Bausch Site 103 — Peoria, Arizona, United States
- Bausch Site 180 — Phoenix, Arizona, United States
- Bausch Site 153 — Phoenix, Arizona, United States
- Bausch Site 248 — Tempe, Arizona, United States
- Bausch Site 222 — Tucson, Arizona, United States
- Bausch Site 150 — Little Rock, Arkansas, United States
- Bausch Site 164 — Bakersfield, California, United States
- Bausch Site 196 — Chula Vista, California, United States
- Bausch Site 226 — Chula Vista, California, United States
- Bausch Site 174 — Escondido, California, United States
- Bausch Site 163 — Fresno, California, United States
- Bausch Site 242 — Garden Grove, California, United States
- Bausch Site 115 — La Jolla, California, United States
- Bausch Site 141 — Lancaster, California, United States
- Bausch Site 140 — Los Angeles, California, United States
- Bausch Site 189 — Los Angeles, California, United States
- Bausch Site 227 — Orange, California, United States
- Bausch Site 199 — Pasadena, California, United States
- Bausch Site 119 — Redwood City, California, United States
- Bausch Site 102 — Rialto, California, United States
- Bausch Site 177 — San Diego, California, United States
- Bausch Site 171 — San Francisco, California, United States
- Bausch Site 214 — San Jose, California, United States
- Bausch Site 182 — Dothan, Alabama, United States
Full record on ClinicalTrials.gov
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