Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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.
EXCLUSION CRITERIA
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 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.
Study’s details
Contition
Hepatic Encephalopathy
Age (in years)
18 - 85
Phase
Phase 3
Participants needed
466
Est. Completion Date
Jan 31, 2025
Treatment type
Interventional
Sponsor
Bausch Health Americas, Inc.
ClinicalTrials.gov identifier
NCT05297448
Study number
RNLC3132
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