Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis
This research study is looking at a new version of a medicine called Rifaximin SSD. Its main goal is to find out if this medicine can help delay the first serious episode of a condition called Hepatic Encephalopathy (HE) in people who have liver cirrhosis, which is scarring of the liver. Hepatic Encephalopathy can cause confusion and other brain-related problems due to liver failure. The study is comparing Rifaximin SSD to a placebo, which is a dummy pill with no active medicine. This helps researchers see if any changes are truly due to the medicine or something else. It's a 'Phase 3' study, meaning it's a later stage of testing, often involving more people, to confirm the medicine's effectiveness and safety before it might become widely available.
At a glance
What is this study about?
This research study is about a condition called Hepatic Encephalopathy, often shortened to HE. HE can affect people with severe liver scarring, known as cirrhosis. When the liver isn't working properly, harmful substances can build up in the blood, reaching the brain and causing problems like confusion, memory issues, or changes in personality. This study is specifically looking at preventing the first serious episode of HE, which doctors call 'overt decompensation'.
The study aims to see if a medicine called Rifaximin SSD can help. Researchers want to find out if this medicine can delay when a person with cirrhosis experiences their first noticeable HE episode. They will be comparing Rifaximin SSD to a 'placebo' – a pill that looks exactly like the study medicine but contains no active drug. This is important science, as it helps doctors tell if any positive effects are truly due to Rifaximin SSD or just a general improvement or expectation.
By carefully studying Rifaximin SSD, scientists hope to find a new way to prevent or delay these challenging HE episodes, improving the quality of life for people living with cirrhosis. If successful, this could offer a valuable new treatment option for many patients.
Key takeaways
- This study is for people with liver scarring (cirrhosis) and fluid in the tummy (ascites).
- It tests if a medicine called Rifaximin SSD can delay serious brain problems (Hepatic Encephalopathy).
- You'll either get the study medicine or a dummy pill (placebo).
- Regular visits and health checks will be part of taking part.
- The study aims to improve care for people with cirrhosis.
Who may be eligible?
To join this study, you would need to have a diagnosis of liver scarring (cirrhosis) and have 'medically controlled ascites'. Ascites means you have fluid build-up in your tummy, but it must be managed with medication and not require frequent procedures to drain the fluid. You also need to be aged between 18 and 85 years old.
There are also some things that would mean you couldn't join. For example, if you've recently had a serious episode of Hepatic Encephalopathy (HE) that caused noticeable symptoms, or if you've had certain other serious liver-related complications like a severe infection (spontaneous bacterial peritonitis) or bleeding in the gut. You also couldn't join if you currently have an unresolved COVID-19 infection.
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 you have a diagnosis of liver cirrhosis?
- Do you have fluid in your tummy (ascites) that is well-controlled by medication?
- Are you between 18 and 85 years old?
- Have you *not* had a serious episode of Hepatic Encephalopathy recently?
- Have you *not* had certain serious liver infections or bleeding recently?
- Do you *not* have an active, unresolved COVID-19 infection?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to receive either the Rifaximin SSD medication or a placebo (dummy pill). Neither you nor your study doctor would know which one you are taking – this is called 'double-blind'. You would take the study medication regularly as instructed. You would have a series of visits to the study clinic over a period of time, where the study team would monitor your health and how you are responding to the treatment. These visits would involve check-ups, potentially some blood tests, and assessments to see if the medication is helping to delay Hepatic Encephalopathy. The total duration of your participation in the study would be explained by the research team.
Potential risks and benefits
Locations (188)
- Bausch Site 591Verified postcodeHomewood, United States
- Bausch Site 445Verified postcodeChandler, United States
- Bausch Site 453Verified postcodeSun City, United States
- Bausch Site 587Verified postcodeTucson, United States
- Bausch Site 550Verified postcodeBakersfield, United States
- Bausch Site 415Verified postcodeCoronado, United States
- Bausch Site 585Verified postcodeCovina, United States
- Bausch Site 585Verified postcodeCovina, United States
- Bausch Site 592Verified postcodeFresno, United States
- Bausch Site 582Verified postcodeLancaster, United States
- Bausch Site 590Verified postcodeLong Beach, United States
- Bausch Site 414Verified postcodeLos Angeles, United States
Common questions
What is Hepatic Encephalopathy (HE)?
HE is a brain condition sometimes seen in people with severe liver problems. It can cause confusion, forgetfulness, or changes in mood because the liver isn't clearing toxins from the blood.
What is a 'placebo'?
A placebo is a dummy pill that looks like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects accurately.
What does 'double-blind' mean?
It means neither you nor your study doctor will know whether you are receiving the real medicine or the placebo. This helps make the study results fair and unbiased.
Are there any costs for taking part?
Generally, you won't have to pay for the study medicine or assessments. Any potential travel costs or compensation would be discussed with you by the study team.
Can I leave the study at any time?
Yes, absolutely. Your participation is completely voluntary, and you can withdraw from the study at any point without it 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
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.