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THE EFFICACY AND SAFETY OF RIFAXIMIN SOLUBLE SOLID DISPERSION (SSD) TABLETS FOR THE DELAY OF ENCEPHALOPATHY DECOMPENSATION IN CIRRHOSIS (RED-C)

Title A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RIFAXIMIN SOLUBLE SOLID DISPERSION (SSD) TABLETS FOR THE DELAY OF ENCEPHALOPATHY DECOMPENSATION IN CIRRHOSIS (RED-C)
Therapeutic Area Cirrhosis
Principal Investigator Dr. Karagozian
Min Age 18 Years
Max Age 70 Years
Gender Any
Contact Obinna Abalihi (Obi)
617-636-0653
oabalihi@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT05071716

Overview

The primary objective of this study is to assess the efficacy of rifaximin SSD-40IR versus placebo to delay the occurrence of HE-related hospitalization. 

Study Details

Inclusion Criteria

Participant has a 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). 

Exclusion Criteria

  • Participant has an active coronavirus disease 2019 (COVID-19) infection that is unresolved or, in the opinion of the investigator, may affect evaluation of the study drug or place the subject at undue risk
  • Participant has a history of anaphylaxis or hypersensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any of the components of rifaximin.
  • Participant consumes more than moderate amounts of alcohol, defined as 1 standard drink per day for women and 2 standard drinks per day for men.

Study Requirements

Participant participation will be up to 20 months, including screening, treatment, and follow-up. Participants will complete a 28-day Screening Period, a 72-week Treatment Period, and a 4-week Follow-up Period. Participants who successfully complete the Screening Period will enter the Treatment Period and will be randomized in a 1:1 allocation to 1 of 2 treatment groups (the other group being placebo). All treatments will be administered BID (twice a day). This study will have 14 scheduled study visits over a period of 80 weeks. Clinic visits will start at Randomization and occur every four weeks from Week 4 through Week 72 and through End of study period. The study includes a post-dosing study visit that will occur 4 weeks after the last dose of study drug.The study assessments will include, reviewing your medical history, collecting blood/urine samples to monitor your health, 12-lead EGG, physical exams, and answering study related questions about your health and lifestyle.