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.
Sites are located in the cities/states identified with the red pin:
Participants will be in the study for up to 80 weeks (about 1.5 years). The study includes the following periods:
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.