Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis (RED-C-3131)
M
Marwan Ghabril
Primary Investigator
Administratively Closed
18 years - 85 years
All
Phase
3
466 participants needed
1 Location
Brief description of study
Study RNLC3131 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter studyhe efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episodevert hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by thedically controlled ascites.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Hepatic Encephalopathy
-
Age: 18 years - 85 years
-
Gender: All
Key Inclusion Criteria:
- Diagnosis of liver cirrhosis with medically controlled ascites (>30 days) notquiring 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)
Updated on
02 Apr 2025.
Study ID: RNLC3131, GI-SALIX-RED-C-3131, 14929
