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: NCT05297448
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-28
• Study Start: 2022-08-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 466

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

Trial Locations

Locations (187)

Bausch Site 591; 🇺🇸 Homewood, Alabama, United States

Bausch Site 445; 🇺🇸 Chandler, Arizona, United States

Bausch Site 453; 🇺🇸 Sun City, Arizona, United States

Bausch Site 587; 🇺🇸 Tucson, Arizona, United States

Bausch Site 550; 🇺🇸 Bakersfield, California, United States

Bausch Site 415; 🇺🇸 Coronado, California, United States

Bausch Site 585; 🇺🇸 Covina, California, United States

Bausch Site 592; 🇺🇸 Fresno, California, United States

Bausch Site 582; 🇺🇸 Lancaster, California, United States

Bausch Site 590; 🇺🇸 Long Beach, California, United States

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