A clinical study evaluating an investigational treatment for adults with liver cirrhosis

Trial ID: NCT05071716

The Red-C 3131 Study is a Phase 3 clinical study to determine the effectiveness and safety of the study medicine, Rifaximin, in delaying hepatic encephalopathy (HE) in adults with liver cirrhosis.

Trial Details

This study aims to recruit around 466 individuals who have been diagnosed with cirrhosis. They will be randomly assigned to receive either the experimental medication, rifaximin, or a placebo, which is a substance that resembles the medication but does not contain any of its active ingredients. The study will last for up to 80 weeks, including screening, treatment, and follow-up. The primary objective of the study is to determine how effective the medication is compared to the placebo in slowing down the first occurrence of hepatic encephalopathy (HE) that requires hospitalization in people with liver disease. HE is a condition in which the liver is unable to prevent toxins from reaching the brain, leading to impaired brain function. The symptoms of HE may include confusion and difficulty in processing thoughts.

Estimated Enrollment

466 Participants

Phase

3

Eligibility Criteria

Participants must:

Be between the ages of 18 and 85
Have a diagnosis of liver cirrhosis and currently being treated for ascites with medication or diet

Participants must not:

Have been diagnosed with overt HE (a severe form of HE)
Have experienced any cognitive issues due to HE or any other illness
Have any current or active infections including COVID-19

Trial Sites

Sites are located in the cities/states identified with the red pin:

What Will Happen in This Study

Participants will be in the study for up to 80 weeks (about 1.5 years). The study includes the following periods:

Screening Period (up to 4 weeks): Will last up to 4 weeks and may take place over more than one visit. Participants will have tests done to see if they qualify for the study.
Study Treatment Period (72 weeks):
- Once participants are found eligible, they will be randomly assigned to one of two study treatment groups: the study medicine or the placebo (which contains no active ingredients). This means participants have a 50/50 chance of receiving the study medicine.
- Both study groups will take the study medicine or placebo as a pill twice a day.
- The study is double-blind, which means neither the participants nor the study team will know which study treatment they are receiving.
- Participants who develop OHE (overt HE, the severe form of HE) will be treated by the study team and followed for the remainder of the study.

Follow-up Period (4 weeks): Participants will attend a Follow-up Visit 4 weeks after they stop taking the study medicine. At this visit, the study team will perform a final round of tests to check participants’ health, as well as the effectiveness and safety of the study medicine. Even if participants stop taking the study medicine or leave the study early, we ask that they still attend the End- of-Treatment Visit and Follow-up Visit.

Frequently Asked Questions (FAQs)

Will compensation for time be available as part of this clinical trial?

Reasonable study-related travel expenses may be included as part of your participation in this clinical trial.

What is a clinical trial?

Through clinical research, scientists and doctors can determine whether a new medical strategy, drug, vaccine, or device is safe and effective for people. New treatments cannot be discovered without clinical trials, which rely on potential trial participants like you to evaluate the safety and effectiveness of these treatments. Participation in a clinical trial is voluntary. Trial participants should have the intention to complete the trial, but they may leave the trial at any time after they join.

What is a Phase 3 clinical trial?

Drugs that enter Phase 3 trials have already been studied in other clinical trials. Researchers have gathered information about the safety of the drug already, usually in up to several hundred people. Phase 3 trials usually include large numbers of participants. Some Phase 3 trials are conducted in multiple countries and include thousands of people. Phase 3 trials are used to collect even more information about how safe a drug is and how well it works.

Can I quit at any time

Trial volunteers have the right to drop out of the trial at any time for any reason or no reason at all. The trial doctor or sponsor also has the right to discontinue a trial volunteer at any time for the participant’s safety or if the participant no longer meets the trial requirements. When withdrawing from the trial, you should let the research team know about it.

What personal information is collected about me during this trial?

The trial doctor and other trial staff will collect your personal information. This may include: - Your name, address, telephone number, and health insurance number, where applicable - Your age, sex, and ethnic and racial background - Your lifestyle information - Your medical history details - Your trial treatment and your response to this treatment - Data resulting from testing your biological samples.

Who has access to my personal information?

All personal information collected for this trial will be securely stored in the trial medical records at the clinical trial site. Sponsor staff, review boards, ethics committees (that approve and monitor studies), and others who have a need to know, such as our data hosting provider and government regulators, may check trial records. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify trial procedures and/or data. If you share your personal data with a clinical trial site, that data will be used by Citeline Connect to contact you about clinical studies and related

What is a placebo?

A placebo is a treatment that looks exactly like an investigational drug but contains no active ingredients. In clinical trials, researchers often compare an investigational drug with a placebo. All the participants receive the same level of quality care, regardless of whether they are assigned to receive the investigational drug or the placebo – the only difference is whether they actually receive the trial drug. This helps researchers better evaluate the true effects of the drug.

This trial is not actively recruiting.