What is the mechanism of action of this treatment?

Common treatments for encephalopathy, such as Rifaximin SSD-40mg IR, primarily work by altering gut microbiota and reducing ammonia production. Rifaximin is a non-absorbable antibiotic that targets gut bacteria responsible for producing ammonia, a neurotoxin that can exacerbate encephalopathy. By reducing the population of these bacteria, Rifaximin lowers ammonia levels in the blood, thereby alleviating symptoms. This mechanism is crucial for encephalopathy patients as it directly addresses one of the primary causes of their condition, leading to improved cognitive function and quality of life.

What side effects are associated with this type of intervention?

Common treatments for encephalopathy that alter gut microbiota and reduce ammonia production, such as Rifaximin, may cause side effects including nausea, flatulence, abdominal pain, and headache. In some cases, patients may experience more severe gastrointestinal disturbances like diarrhea or constipation. Additionally, long-term use of antibiotics like Rifaximin can lead to antibiotic resistance and alterations in the gut microbiome, potentially resulting in secondary infections such as Clostridioides difficile.

What prior FDA approvals exist?

Rifaximin is an FDA-approved antibiotic used to treat hepatic encephalopathy by altering gut microbiota and reducing ammonia production. It is effective in preventing episodes of overt hepatic encephalopathy in patients with liver cirrhosis. Other related treatments include lactulose, a non-absorbable disaccharide that also helps reduce blood ammonia levels by promoting its excretion through the gastrointestinal tract.

What other types of research exist?

Promising alternatives to Rifaximin SSD-40mg IR for encephalopathy patients may include other antibiotics like neomycin or metronidazole, probiotics that help modulate gut microbiota, and lactulose, which reduces ammonia absorption in the gut. These alternatives should be discussed with a healthcare provider to determine the best treatment plan.

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Antibiotic

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

Phase 3

Waitlist Available

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

Be older than 18 years old

Must not have

Active COVID-19 that is unresolved

History of SBP

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have COVID-19.

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I have a history of spontaneous bacterial peritonitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

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

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for encephalopathy, such as Rifaximin SSD-40mg IR, primarily work by altering gut microbiota and reducing ammonia production. Rifaximin is a non-absorbable antibiotic that targets gut bacteria responsible for producing ammonia, a neurotoxin that can exacerbate encephalopathy. By reducing the population of these bacteria, Rifaximin lowers ammonia levels in the blood, thereby alleviating symptoms. This mechanism is crucial for encephalopathy patients as it directly addresses one of the primary causes of their condition, leading to improved cognitive function and quality of life.