Red-C 3131 Study

This study is looking to see if a study medicine can safely delay or prevent hepatic encephalopathy (HE) in adults with liver cirrhosis.

The study drug called rifaximin will be compared with a placebo. A placebo looks exactly like the study drug but contains no active medication.

You may be able to take part in this study if you:

  • Are between the ages of 18 and 85

  • Have been diagnosed with liver cirrhosis

  • Have not been diagnosed with overt HE (a severe form of HE)

  • Do not experience any cognitive issues due to HE or any other illness

  • Do not have an active COVID-19 infection

What is the Red-C 3131 Study?

The Red-C 3131 Study will last up to 80 weeks and is made up of 3 parts:

Part 1

Screening (up to 4 weeks)

If you are interested in taking part, you will be invited to Lucida Clinical for assessments. Participants will undergo testing to see if they qualify to participate in the study.

Part 2

Study treatment (72 weeks)

Once participants are found eligible, they will be randomly assigned to receive either the study medicine or placebo. They will take their assigned study medicine or placebo twice a day for 72 weeks.

Part 3

Follow-up (4 weeks)

Four weeks after participants have stopped taking the study medicine they will return to Lucida Clinical for final health checks.

Red-C 3131 Study Q & A

  • Hepatic encephalopathy (HE) is a complication of liver cirrhosis (liver damage). It affects nearly half of people with cirrhosis. Because of the damage, the liver doesn’t work as well as it should, and some toxins stay in the body. HE occurs when too many toxins build up in the bloodstream and reach the brain. It can cause symptoms like confusion, personality changes, lack of energy, inappropriate behavior, sleep problems, loss of small hand movements and tremors in hands and arms.

  • Participants may be eligible for this study if they:

    • Are between the ages of 18 and 85.

    • Have a diagnosis of liver cirrhosis.

    • Have not been diagnosed with overt HE (a severe form of HE).

    • Do not experience any cognitive issues due to HE or any other illness.

    • Do not have an active COVID-19 infection.

  • Participants will be in the study for up to 80 weeks. They will attend up to 21 study visits, including 14 visits to the clinic and 7 telephone check-ins.

  • The study drug is called rifaximin SSD-401R. Rifaximin is currently FDA-approved to treat diarrhea from irritable bowel syndrome, traveler’s diarrhea and others. It has been prescribed off-label to treat HE.

    The mode of action of antibiotics for the treatment of HE is to reduce the number of deaminating bacteria and urease-producing bacteria, thereby reducing the production of ammonia and other potential toxins.

  • Participants enrolled in this study will be randomly assigned to one of two study treatment groups. One group will receive the study medicine, rifaximin, and the other group will receive a placebo.

    Participants have a 50/50 chance of receiving the study medicine.

    Both study groups will take their assigned study medicine or placebo pill twice a day.

    The study is double-blind, which means neither the participant nor the study team will know which study treatment they are receiving.