Rifaximin for Hepatic Encephalopathy

(RED-C-3132 Trial)

Recruiting at 241 trial locations

Overseen By Nupur Murali

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bausch Health Americas, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests if rifaximin, an oral antibiotic, can delay brain problems in patients with liver cirrhosis and controlled fluid buildup by reducing harmful gut bacteria. Rifaximin has been shown to reduce the recurrence of brain-related issues and related hospitalizations.

Research Team

Michael Mader

Principal Investigator

Bausch Health

Eligibility Criteria

This trial is for adults aged 18-85 with liver cirrhosis and controlled fluid buildup in the abdomen. Participants must have a clear mental state (MMSE score >24) and no severe brain dysfunction (Conn score <2). Those with recent serious infections, internal bleeding, kidney issues, or past overt hepatic encephalopathy are excluded.

Inclusion Criteria

Your memory and thinking skills are good, and you score more than 24 on a test called Mini-Mental State Examination (MMSE).

I have liver cirrhosis with stable fluid buildup not needing fluid removal.

I am between 18 and 85 years old.

Exclusion Criteria

I currently have COVID-19.

I have a history of spontaneous bacterial peritonitis.

You have a history of severe liver swelling (Conn score ≥ 2).

Treatment Details

Interventions

• Rifaximin SSD (Antibiotic)

Trial Overview The study compares Rifaximin SSD-40mg IR against a placebo to see if it can delay the first episode of overt hepatic encephalopathy—a severe liver-related brain disorder—in patients with liver cirrhosis. It's randomized and double-blind, meaning neither doctors nor patients know who gets the real treatment.

Participant Groups

Group I: Rifaximin SSD-40mg IR Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bausch Health Americas, Inc.

Lead Sponsor

Trials

265

Recruited

82,000+

Dr. Jonathan Sadeh

Bausch Health Americas, Inc.

Chief Medical Officer

MD from Mount Sinai School of Medicine, MSc in Clinical Research from Harvard Medical School

Thomas J. Appio

Bausch Health Americas, Inc.

Chief Executive Officer since 2021

Bachelor's degree in Biology from Rutgers University