A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RIFAXIMIN SOLUBLE SOLID DISPERSION (SSD) TABLETS FOR THE DELAY OF ENCEPHALOPATHY DECOMPENSATION IN CIRRHOSIS (RED-C)
This research study is investigating a new version of a medication called Rifaximin. It aims to find out if this drug can effectively delay or prevent episodes of a serious condition called hepatic encephalopathy (OHE) in people who have advanced liver disease (cirrhosis). OHE can cause confusion and other brain-related issues, often requiring hospitalisation. Participants will either receive the active drug or a placebo (a dummy pill with no active medicine) to see how well the new Rifaximin works. The study will especially focus on whether it can reduce the need for hospital stays due to OHE. All diagnoses will be carefully checked by medical experts.
At a glance
What is this study about?
This study focuses on a condition called hepatic encephalopathy (OHE), which can affect people with severe liver disease, also known as cirrhosis. When the liver isn't working properly, toxins can build up in the blood and affect the brain, leading to confusion, memory problems, and sometimes a coma. These episodes can be very serious and often require hospital treatment. Our goal is to find better ways to help people avoid these difficult and life-threatening events.
The researchers are testing a new version of a medicine called Rifaximin. You might have heard of Rifaximin before, as it's already used for some gut conditions. This new version is designed to dissolve differently, and we want to see if it's more effective at preventing OHE. The core idea is to compare how people fare when they take this new Rifaximin compared to those who take a 'dummy' pill, called a placebo, which contains no active medicine.
Throughout the study, medical professionals will closely monitor participants. A key part of the study is to see if the new Rifaximin can reduce the number of times people need to go to hospital because of OHE. This kind of research is really important because it helps us find new and improved treatments to manage the effects of liver disease and improve the lives of those living with it.
Key takeaways
- The study is testing a new form of Rifaximin for liver disease patients.
- It aims to prevent serious brain problems (OHE) and hospitalisation.
- Participants will receive either the new drug or a dummy pill.
- Regular health checks and monitoring will be part of taking part.
- You have the right to withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. Both men and women are welcome.
One of the main requirements is that you must have been diagnosed with advanced liver disease, also known as cirrhosis, and have experienced episodes of hepatic encephalopathy (OHE) in the past. This means you've had periods where your liver problems affected your brain, causing confusion or other symptoms.
The medical team will carefully review your health information to make sure the study is a safe and suitable option for you. They will check to see if your specific health situation matches the study's requirements.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of advanced liver disease (cirrhosis)?
- Have you experienced episodes of hepatic encephalopathy (OHE) in the past?
- Are you able to attend regular clinic visits for monitoring?
What does participation involve?
If you decide to take part in this study, you will be given either the new Rifaximin medication or a placebo (a dummy pill). You won't know which one you're receiving, nor will the study team, until the study is over. You'll take these tablets as instructed by the doctors.
Your participation will involve regular visits to the clinic. During these visits, the medical team will carry out health checks, ask about your symptoms, and may take blood or urine samples to see how you're responding to the treatment. They will also look out for any hospitalisations you might have due to your condition.
The total length of time you'll be involved in the study will be decided by your doctor based on how your treatment progresses, and will involve continuous assessment and follow-up to monitor your health and the effectiveness of the medication.
Potential risks and benefits
Locations (8)
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedBelgium
- —UnverifiedBulgaria
Common questions
What is hepatic encephalopathy (OHE)?
OHE is a brain problem that can happen to people with severe liver disease. It occurs when toxins build up in the blood, affecting how the brain works, and can cause confusion or memory issues.
What is a placebo?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps researchers compare the effects of the new drug more accurately.
Will I know if I'm getting the real drug or the placebo?
No, neither you nor the doctors involved will know whether you are receiving the active drug or the placebo until the study is finished. This is called 'double-blind'.
How long will I be in the study?
The study duration will depend on your individual health needs and how your condition progresses, as monitored by the medical team.
What does a 'multicenter study' mean?
It means the study is happening at several different hospitals or clinics, not just one. This helps researchers gather information from more people.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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