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

Phase 3

Active, not recruiting

• Conditions: Hepatic Encephalopathy
• Interventions: Drug: Placebo; Drug: Rifaximin SSD

• Registration Number: NCT05071716
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-08
• Study Start: 2022-04-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 524

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Rifaximin SSD-40mg IR	Rifaximin SSD	-

Primary Outcome Measures

Name	Time	Method
Time to first event of overt hepatic encephalopathy requiring hospitalization	72 weeks

Secondary Outcome Measures

Name	Time	Method
Time to first Conn score ≥ 2	72 weeks
Time to all-cause hospitalization	72 weeks
Time to first event of OHE that requires hospitalization, or all-cause death	72 weeks

Trial Locations

Locations (150)

Bausch Site 182; 🇺🇸 Dothan, Alabama, United States

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

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