For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Diagnosis of liver cirrhosis with medically controlled ascites (>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past).
  2. Conn (West Haven Criteria) score of < 2.
  3. Mini-Mental State Examination (MMSE) score > 24 at screening.
  4. ≥ 18 and ≤ 85 years of age. Key

EXCLUSION CRITERIA

  1. Active COVID-19 that is unresolved
  2. History of SBP
  3. History of EVB or AKI-HRS within 6 months
  4. History of OHE episode (Conn score ≥ 2)
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 908-541-8631Email iconEmail Study Center

Study’s details


Contition

Hepatic Encephalopathy

Age (in years)

18 - 85

Phase

Phase 3

Participants needed

466

Est. Completion Date

Jan 2025

Treatment type

Interventional


Sponsor

Bausch Health Americas, Inc.

ClinicalTrials.gov identifier

NCT05297448

Study number

RNLC3132

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