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Antibiotic

Rifaximin for Hepatic Encephalopathy (RED-C-3132 Trial)

Phase 3
Recruiting
Research Sponsored by Bausch Health Americas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 and ≤ 85 years of age
Diagnosis of liver cirrhosis with medically controlled ascites (>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 weeks
Awards & highlights
Pivotal Trial

RED-C-3132 Trial Summary

This trial will test whether rifaximin can help delay the first episode of overt hepatic encephalopathy (OHE) in people with advanced liver cirrhosis.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of Rifaximin may include abdominal pain, nausea, dizziness, fatigue, peripheral edema (swelling), anemia (low red blood cell count), rash or itching. The exact side effects will be monitored throughout the trial.

RED-C-3132 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 85 years old.
Select...
I have liver cirrhosis with stable fluid buildup not needing fluid removal.

RED-C-3132 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to first event of overt hepatic encephalopathy requiring hospitalization
Secondary outcome measures
Time to all-cause hospitalization
Time to first Conn score ≥ 2
Time to first event of OHE that requires hospitalization, or all-cause death

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

RED-C-3132 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Rifaximin SSD-40mg IRExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin SSD
2015
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
261 Previous Clinical Trials
81,554 Total Patients Enrolled
Michael MaderStudy DirectorBausch Health
1 Previous Clinical Trials
466 Total Patients Enrolled
John LaheyStudy DirectorBausch Health
5 Previous Clinical Trials
1,012 Total Patients Enrolled

Media Library

Rifaximin SSD (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05297448 — Phase 3
Encephalopathy Research Study Groups: Rifaximin SSD-40mg IR, Placebo
Encephalopathy Clinical Trial 2023: Rifaximin SSD Highlights & Side Effects. Trial Name: NCT05297448 — Phase 3
Rifaximin SSD (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05297448 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for this research project 25 years or older?

"This study's age requirements for participants are that they must be 18 or older, and no more than 85 years old."

Answered by AI

Can people with the target condition participate in this research project at this time?

"Yes, the trial is still open for recruitment and recent updates to the posting on clinicaltrials.gov were made on September 22nd, 2020. The trial is looking for 466 participants total, which will be recruited from 54 different medical facilities."

Answered by AI

Could I potentially be a candidate for this research project?

"Up to 466 patients, who are between 18-85 years old and have hepatic coma, will be accepted into this trial. In addition to meeting the age requirements, it is essential that patients also meet the followingConn (West Haven Criteria) score of < 2., ≥ 18 and ≤ 85 years of age., Key, 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)., Mini-Mental State Examination (MMSE) score > 24 at screening and"

Answered by AI

Has Rifaximin SSD gone through the FDA's okay process?

"As this is a Phase 3 trial, meaning that there is both evidence of efficacy and multiple rounds of data supporting safety, Rifaximin SSD is estimated to be a 3 on a scale of 1 to 3 by our team at Power."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Bausch Site 561
Bausch Site 546
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~166 spots leftby Jan 2025