Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
This study is for people with serious liver scarring, called cirrhosis, who also have fluid build-up in their tummy that is being managed by medication. The main aim is to test a new version of a drug called Rifaximin to see if it can prevent or delay a serious brain condition called hepatic encephalopathy (OHE), which can happen when the liver isn't working well. Participants will either receive the new Rifaximin or a placebo (a dummy drug with no active medicine) in a random way, meaning neither the patient nor the doctors will know who is getting what. This is to fairly check if the new Rifaximin is safe and effective in delaying this brain complication.
At a glance
What is this study about?
This research study is about a problem called hepatic encephalopathy, which is a brain condition sometimes developed by people with advanced liver disease, such as cirrhosis. When your liver is not working properly, toxins can build up in your blood and affect your brain, leading to confusion, memory problems, and changes in personality. This study specifically focuses on delaying the first serious episode of this brain condition.
The study is testing a new version of a medication called Rifaximin. You might already know of Rifaximin as it's used for some gut issues and also to manage existing hepatic encephalopathy. This new version is designed to be more easily absorbed by the body. Researchers want to see if taking this new Rifaximin can prevent or slow down these serious brain problems in people who currently have managed fluid build-up in their tummy due to cirrhosis, but haven't yet had a severe episode of hepatic encephalopathy.
By comparing the new Rifaximin with a placebo (a dummy pill containing no active medicine), the researchers hope to understand if it is effective and safe. Finding an effective way to prevent or delay these serious brain complications could significantly improve the quality of life for people living with cirrhosis.
Key takeaways
- Tests a new Rifaximin medicine for severe liver disease.
- Aims to delay brain complications like confusion (hepatic encephalopathy).
- Compares the new medicine to a dummy pill (placebo).
- Suitable for people aged 18-85 with managed fluid build-up in their tummy.
- Involves regular clinic visits and health checks.
Who may be eligible?
To join this study, you need to have a diagnosis of liver scarring (cirrhosis) and have fluid in your tummy (ascites) that is well-controlled with medication – meaning you haven't needed to have fluid drained recently, even if you had it drained in the past. Your brain function will be checked; you shouldn't have signs of severe confusion or memory problems, and you must not have had a serious episode of hepatic encephalopathy before.
Participants must be between 18 and 85 years old.
There are some reasons why you might not be able to join. For example, if you currently have an uncontrolled COVID-19 infection, or if you've had certain serious infections (like a bad belly infection) or other serious liver-related problems (like bleeding from your gullet or kidney failure) within the last six months.
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.
- Do I have scarring of the liver (cirrhosis)?
- Is my stomach fluid (ascites) controlled with medicine, without needing drainage recently?
- Have I never had a serious episode of confusion or memory problems due to my liver?
- Am I between 18 and 85 years old?
- Do I currently feel generally well without an active COVID-19 infection or other serious infections recently?
What does participation involve?
If you decide to take part, you'll be randomly assigned to receive either the new Rifaximin medicine or a placebo (dummy medicine). You and your study doctors won't know which one you're getting. You'll take this medicine regularly. You will have regular visits to the clinic for health checks, blood tests, and to assess how you're feeling and thinking throughout the study. The doctors will monitor you closely for any changes in your health. The total duration of your participation in the study, including all visits and follow-up, will be explained by the study team, but clinical trials like this often last for a year or more.
Potential risks and benefits
Locations (150)
- Bausch Site 182Verified postcodeDothan, United States
- Bausch Site 129Verified postcodeChandler, United States
- Bausch Site 103Verified postcodePeoria, United States
- Bausch Site 180Verified postcodePhoenix, United States
- Bausch Site 153Verified postcodePhoenix, United States
- Bausch Site 248Verified postcodeTempe, United States
- Bausch Site 222Verified postcodeTucson, United States
- Bausch Site 150Verified postcodeLittle Rock, United States
- Bausch Site 164Verified postcodeBakersfield, United States
- Bausch Site 196Verified postcodeChula Vista, United States
- Bausch Site 226Verified postcodeChula Vista, United States
- Bausch Site 174Verified postcodeEscondido, United States
Common questions
What is 'cirrhosis'?
'Cirrhosis' is severe scarring of the liver, which can stop it from working properly.
What is 'hepatic encephalopathy'?
It's a brain condition that can happen with severe liver disease, causing confusion or memory problems.
What is a 'placebo'?
A placebo is a dummy pill that looks like the study drug but contains no active medicine, used for fair comparison.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know until after the study ends.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time without affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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