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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



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)