Hepatic Encephalopathy
Conditions
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.
Interventions
DRUGRifaximin SSD
Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily
DRUGPlacebo
Placebo Twice Daily
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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. 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first event of overt hepatic encephalopathy requiring medical intervention in hospital/ER/ED/clinic or death. | 72 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to first Conn score ≥ 2 or confirmed OHE requiring medical intervention in hospital/ER/ED/ clinic or death | 72 weeks |
| Time to all-cause hospitalization | 72 weeks |
| Time to first event of OHE that requires hospitalization, or all-cause death | 72 weeks |
Countries
Australia, Canada, Puerto Rico, United States
Outcome results
None listed