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Study on Rifaximin for Delaying Hepatic Encephalopathy in Cirrhosis Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Hepatic Encephalopathy, which is a complication that can occur in people with liver cirrhosis. The trial is investigating the use of a medication called Rifaximin, specifically in the form of 40 mg Soluble Solid Dispersion Immediate Release Tablets (SSD-40IR). The purpose of the study is to determine if Rifaximin can help delay the worsening of symptoms associated with this condition, which often leads to hospitalization.

Participants in the study will be randomly assigned to receive either the Rifaximin tablets or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The study will take place over a period of time, during which participants will be monitored for any signs of their condition worsening, particularly those that might require hospitalization.

The main goal is to see how long it takes for participants to experience a significant event related to their condition, such as a hospitalization due to Hepatic Encephalopathy. The study will also look at other factors, such as the time it takes for any cause of hospitalization or serious health events to occur. This research aims to provide valuable information on the effectiveness and safety of Rifaximin in managing this serious liver-related condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be required to provide written informed consent. This involves reading and understanding the consent form, which outlines the study's purpose, procedures, and potential risks and benefits.

    The participant must meet specific eligibility criteria, including having a diagnosis of liver cirrhosis with controlled ascites, a Conn score of less than 2, and a Mini-Mental State Examination score greater than 24.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm the participant's eligibility. This includes a thorough medical evaluation and confirmation of the diagnosis of hepatic encephalopathy (OHE) by a trained medical professional.

    A pregnancy test will be conducted for females of childbearing potential, and all participants must agree to use effective contraception methods during the study.

  3. Step 3

    Medication administration

    Participants will be randomly assigned to receive either the study medication, rifaximin 40 mg soluble solid dispersion immediate release tablets (SSD-40IR), or a placebo. The medication is taken orally in tablet form.

    The dosage and frequency of administration will be determined by the study protocol, and participants will be instructed on how to take the medication as part of their daily routine.

  4. Step 4

    Ongoing monitoring

    Throughout the study, participants will undergo regular monitoring to assess their health and the effectiveness of the treatment. This includes scheduled visits to the study center for evaluations and tests.

    Participants will be monitored for any side effects or adverse reactions to the medication, and their progress will be documented by the study team.

  5. Step 5

    Completion of the study

    At the end of the study period, participants will undergo a final assessment to evaluate the outcomes of the treatment. This includes a review of their medical condition and any changes observed during the study.

    Participants will be informed of the study results and any further steps or follow-up care that may be necessary.

Who can join the trial?

6 criteria

  • The participant must have a diagnosis of liver cirrhosis with medically controlled ascites for more than 30 days. Ascites is a condition where fluid builds up in the abdomen. It should be controlled by diet or medication and should not require frequent medical procedures to remove the fluid.
  • The participant must have a Conn (West Haven Criteria [WHC]) score of less than 2. This is a scale used to measure the severity of confusion or altered mental state due to liver disease.
  • The participant must have a Mini-Mental State Examination (MMSE) score greater than 24 at screening. This is a test that checks mental functions like memory and understanding.
  • The participant must be between 18 and 85 years old.
  • Females who can have children must have a negative pregnancy test at the start of the study. All participants must agree to use highly effective birth control methods during the study.
  • The participant must be able to read, understand, and sign a consent form on their own, which is approved by an ethics committee. This form explains the study and the participant's rights.

Who cannot join the trial?

10 criteria

  • Patients who have a different condition than **Hepatic Encephalopathy (OHE)** cannot participate. **Hepatic Encephalopathy** is a condition that affects the brain and is caused by liver problems.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not willing to follow the study procedures or take the study medication as directed cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate in this study.
  • Patients who have a history of allergic reactions to the study medication or similar medications cannot participate.
  • Patients who have any other serious medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have a history of substance abuse or alcohol dependency cannot participate.
  • Patients who have had a major surgery recently or are planning to have surgery during the study period cannot participate.
  • Patients who have any condition that, in the opinion of the study doctor, makes them unsuitable for the study cannot participate.
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Investigated drugs

Rifaximin is a medication used in this clinical trial. It is designed to help people with liver disease, specifically cirrhosis, by delaying the worsening of a condition called hepatic encephalopathy. This condition can cause confusion and other mental changes due to liver problems. Rifaximin works by reducing the number of bacteria in the gut that produce toxins, which can affect the brain when the liver is not functioning properly. In this study, the medication is being tested to see if it can help prevent hospitalizations related to this condition.

What is already known about the treatment

Rifaximin Soluble Solid Dispersion (SSD) Tablets – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials to evaluate its effectiveness and safety in delaying the worsening of hepatic encephalopathy, a condition related to liver disease. Rifaximin works by reducing the number of bacteria in the gut, which helps decrease the production of toxins that can affect the brain. It is classified as an antibiotic, specifically targeting the gut to help manage symptoms associated with liver-related brain dysfunction.

Investigated diseases

Hepatic Encephalopathy – Hepatic Encephalopathy is a condition that affects the brain due to liver dysfunction. It occurs when the liver is unable to remove toxins from the blood, leading to a buildup that can affect brain function. Symptoms can range from mild confusion and forgetfulness to severe mental changes and even coma. The progression of the disease can vary, with episodes of worsening symptoms followed by periods of improvement. Factors such as infections, dehydration, or certain medications can trigger or worsen the condition. Over time, repeated episodes can lead to more persistent cognitive impairments.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502899-23-00Protocol codeRNLC3132Estimated enrolment489 patientsSponsorSalix Pharmaceuticals Inc.

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