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 (RED-C-3132)

  • STATUS
    Recruiting
  • End date
    Jan 13, 2025
  • participants needed
    466
  • sponsor
    Bausch Health Americas, Inc.
Updated on 13 October 2022
ascites
encephalopathy
cirrhosis
screening procedures
rifaximin
conn
mini-mental status exam

Summary

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 advanced liver cirrhosis, defined by the presence of medically controlled ascites.

Details
Condition Hepatic Encephalopathy
Treatment Placebo, Rifaximin SSD
Clinical Study IdentifierNCT05297448
SponsorBausch Health Americas, Inc.
Last Modified on13 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of advanced liver cirrhosis with medically controlled ascites (>30 days) not requiring therapeutic paracentesis (prophylactic variceal banding allowed if no history of previous variceal bleeding)
Conn (West Haven Criteria) score of < 2\
Mini-Mental State Examination (MMSE) score > 24 at screening and baseline
≥ 18 and ≤ 85 years of age

Exclusion Criteria

Active COVID-19, history of SBP, EVP or AKI-HRS
History of OHE episode (Conn score ≥ 2)
Use, among others, non-study rifaximin, lactulose/lactitol (with exception of prior occasional, intermittent use of lactulose for non-OHE indications), benzodiazepine, and chronic antibiotics
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