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Clinical Trials in Australia / NCT05297448
Active, not recruiting Phase 3

Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis

NCT05297448 · tracked via the Priya Life Science Australia tracker
Sponsor
Bausch Health Americas, Inc
Phase
Phase 3
Started
2022-08-03
Last updated
2025-09-10

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 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.

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 (188)

FacilityCityRegionStatus
Bausch Site 591 Homewood Alabama
Bausch Site 445 Chandler Arizona
Bausch Site 453 Sun City Arizona
Bausch Site 587 Tucson Arizona
Bausch Site 550 Bakersfield California
Bausch Site 415 Coronado California
Bausch Site 585 Covina California
Bausch Site 585 Covina California
Bausch Site 592 Fresno California
Bausch Site 582 Lancaster California
Bausch Site 590 Long Beach California
Bausch Site 414 Los Angeles California
Bausch Site 405 Orange California
Bausch Site 482 Valencia California
Bausch Site 575 Colorado Springs Colorado
Bausch Site 425 Doral Florida
Bausch Site 449 Hialeah Florida
Bausch Site 558 Hialeah Florida
Bausch Site 418 Hialeah Florida
Bausch Site 468 Hollywood Florida
Bausch Site 495 Miami Florida
Bausch Site 543 Miami Florida
Bausch Site 479 Miami Florida
Bausch Site 428 Miami Florida
Bausch Site 470 Miami Florida
Bausch Site 486 Miami Florida
Bausch Site 552 Miami Florida
Bausch Site 594 Miami Florida
Bausch Site 456 Miami Florida
Bausch Site 458 Miami Florida
Bausch Site 435 Miami Florida
Bausch Site 452 Miami Lakes Florida
Bausch Site 431/443 Ocala Florida
Bausch Site 450 Ocala Florida
Bausch Site 446 Ocoee Florida
Bausch Site 421 Orange City Florida
Bausch Site 596 Orlando Florida
Bausch Site 537 Palmetto Bay Florida
Bausch Site 407 Port Orange Florida
Bausch Site 454 Wellington Florida

+ 148 more sites — see the full list on the official registry below.

More Bausch Health Americas, Inc. trials in Australia

Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis Active, not recruiting

Other trials for the same condition

Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in 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 NCT05297448 on ClinicalTrials.gov ↗ ← All trials in Australia