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 Los Angeles, California and other locations
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, 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 California 90095 United States
  • Bausch Site 140
    Los Angeles California 90033 United States
  • Bausch Site 199
    Pasadena California 91105 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