Randomised, double-blind, placebo-controlled and parallel group trial to investigate the effects of one dose (up-titration to a fixed dose regimen) of oral BI 685509 on portal hypertension after 8 weeks treatment in patients with clinically significant portal hypertension (CSPH) in decompensated cirrhosis after their first decompensation event, who are stabilized CTP 5-7
This research is investigating a new medication, BI 685509, for individuals who have liver disease (cirrhosis) and high blood pressure in the main vein leading to their liver, a condition called portal hypertension. These patients have already experienced some complications from their liver disease, but are now stable. The main goal is to find out if this medicine can reduce the blood pressure in the liver after 8 weeks of treatment. We'll compare it to a dummy medicine (placebo) to understand how well it works and if it helps prevent further serious problems that can arise from liver disease, such as fluid build-up or bleeding.
At a glance
What is this study about?
This study is about a new medicine called BI 685509, which we are testing in people who have advanced liver disease, known as cirrhosis. With cirrhosis, your liver can become scarred, which makes it harder for blood to flow through it. This can cause high blood pressure in the main vein that goes to your liver, a condition called portal hypertension. This high pressure can lead to serious health problems like fluid build-up in the tummy (ascites), bleeding from swollen veins in the gullet (variceal haemorrhage), or problems with thinking and memory (hepatic encephalopathy).
The patients taking part in this study have already experienced one of these serious problems, but their condition is now stable. We want to see if BI 685509 can help lower the high blood pressure in the liver, which we measure as 'HVPG'. By reducing this pressure, we hope to prevent these complications from happening again or getting worse. This is a "Phase II" study, which means we are exploring if the treatment is effective and safe to use.
To ensure we get clear results, some patients will receive the new medicine, while others will get a 'placebo' – a dummy medicine that looks exactly like the real one but has no active ingredient. Neither you nor your doctor will know which you are receiving, which helps us to fairly compare the new medicine's effects.
Key takeaways
- The study tests a new medicine (BI 685509) for high blood pressure in the liver (portal hypertension).
- It's for people with stable, advanced liver disease (cirrhosis) who've had past complications.
- The main goal is to see if the medicine lowers liver blood pressure after 8 weeks.
- Some participants get the active medicine, others get a dummy medicine (placebo).
- Your health will be closely monitored throughout the 8-week treatment period.
- This is a Phase II study, exploring how well the treatment works and its safety.
Who may be eligible?
This study is looking for adults aged 18 and over, of any gender. To be considered, you must have advanced liver disease (cirrhosis) that is not caused by issues with your bile ducts. You should also have high blood pressure in your liver (clinically significant portal hypertension) and have previously experienced a complication from your liver disease, such as fluid build-up in your tummy, bleeding, or memory issues, but your condition must now be stable.
There will be other detailed health checks to make sure the study medicine is safe for you and that you fit the specific requirements for the research. For example, your liver function will be assessed using a scoring system, and you'll need to be within a certain range for that.
It's important to discuss your full medical history with the study doctor, as certain health conditions or medications might mean this study isn't right for you. They will be able to tell you if you meet all the criteria.
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 advanced liver disease (cirrhosis) not caused by bile duct issues?
- Do you have high blood pressure in your liver (portal hypertension)?
- Have you experienced a complication from your liver disease (e.g., fluid build-up, bleeding) in the past, but your condition is now stable?
What does participation involve?
If you decide to take part, you would receive the study medicine (either BI 685509 or a placebo) for 8 weeks. The medicine is taken by mouth. During this time, you would have regular visits to the clinic so the study team can monitor your health and how you are responding to the treatment. This will involve physical examinations, blood tests, and other assessments. One important test will be to measure the blood pressure in your liver (HVPG) at the beginning and again after 8 weeks of treatment to see if it has changed. You might also be asked about any new symptoms or how you are feeling. The exact number of visits and tests will be explained to you in detail by the study team. After the 8-week treatment period, there will be some follow-up appointments to check on your health and any long-term effects.
Potential risks and benefits
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Common questions
What is portal hypertension?
It's high blood pressure in the main vein that carries blood to your liver, often caused by advanced liver scarring (cirrhosis).
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real drug but has no active ingredients. It helps us fairly compare its effects against the new medicine.
What does 'decompensated cirrhosis' mean?
It means your liver disease has caused serious complications like fluid build-up, bleeding, or confusion, but you are now stable.
How is HVPG measured?
HVPG (Hepatic Venous Pressure Gradient) is a special measurement of blood pressure inside your liver, usually done with a small procedure.
How long will I take the study medicine?
You would take the study medicine by mouth for 8 weeks.
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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