This study is in progress, not accepting new patients

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

a study on Hepatic Encephalopathy Cirrhosis

Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

Keywords

Hepatic Encephalopathy, Counterfeit Drugs, Rifaximin SSD, Rifaximin SSD-40mg IR

Eligibility

You can join if…

Open to people ages 18-85

  • 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.

You CAN'T join if...

  • 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)

Locations

  • Bausch Site 189
    Los Angeles 5368361 California 5332921 90095 United States
  • Bausch Site 163
    Fresno 5350937 California 5332921 93701 United States
  • Bausch Site 115
    La Jolla 5363943 California 5332921 92037 United States
  • Bausch Site 171
    San Francisco 5391959 California 5332921 94109 United States
  • Bausch Site 227
    Orange 5379513 California 5332921 92868 United States
  • Bausch Site 242
    Garden Grove 5351515 California 5332921 92844 United States
  • Bausch Site 140
    Los Angeles 5368361 California 5332921 90033 United States
  • Bausch Site 177
    San Diego 5391811 California 5332921 92114 United States
  • Bausch Site 199
    Pasadena 5381396 California 5332921 91105 United States
  • Bausch Site 174
    Escondido 5346827 California 5332921 92025 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bausch Health Americas, Inc.
ID
NCT05071716
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 524 people participating
Last Updated