Randomised, open-label and parallel group trial to investigate the effects of oral BI 685509 alone or in combination with empagliflozin on portal hypertension after 8 weeks treatment in patients with clinically significant portal hypertension (CSPH) in compensated cirrhosis
This research study is for people who have high blood pressure in their liver, a condition known as portal hypertension, specifically when it's linked to liver scarring (compensated cirrhosis). The main goal is to find out if a new medicine, called BI 685509, can effectively lower this liver pressure. Researchers will compare giving BI 685509 by itself, or in combination with an existing drug called empagliflozin. The study will last 8 weeks. Doctors will measure changes in liver pressure to see which treatment works best. They will also keep an eye on any side effects and whether the treatments prevent complications of liver disease. This is an early-stage study to explore new treatment options.
At a glance
What is this study about?
This research study is about a condition called portal hypertension. This happens when there's high blood pressure in the main vein that carries blood to your liver (the portal vein). This is often a problem for people who have liver scarring, known as cirrhosis. The study aims to find out if a new medicine can help reduce this high pressure and potentially prevent complications.
The study will look at a new drug, BI 685509. Researchers want to see if this new drug can help lower liver pressure when given on its own, or if it works even better when combined with an existing medicine called empagliflozin. By lowering this pressure, doctors hope to help people with cirrhosis feel better and reduce their risk of severe problems.
Over 8 weeks, participants will receive one of the study treatments. Doctors will carefully measure changes in liver pressure to see how well each treatment works. They will also monitor for any side effects and track whether the treatments help prevent other issues that can arise from advanced liver disease.
Key takeaways
- Tests new drugs for high blood pressure in the liver (portal hypertension).
- Aims to lower liver pressure in people with compensated cirrhosis.
- Compares a new drug (BI 685509) alone or with an existing drug (empagliflozin).
- Study treatment lasts for 8 weeks.
- Participation involves regular clinic visits and health checks.
- You can stop participating at any time.
Who may be eligible?
To be eligible for this study, you must be 18 years old or older. The study is open to both men and women.
Participants need to have been diagnosed with portal hypertension, which means you have high blood pressure in the main blood vessel leading to your liver. This condition must be linked to compensated cirrhosis, which is a form of liver scarring where your liver is still able to do many of its important jobs.
There will also be other medical checks and criteria that the study doctors will go through with you to make sure the study is a safe and suitable option for your unique health situation.
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 high blood pressure in your liver (portal hypertension)?
- Is your liver problem related to compensated cirrhosis?
- Are you able to attend regular clinic appointments for 8 weeks?
What does participation involve?
If you decide to take part in this study, you will be given a study medicine to take, either BI 685509 alone or in combination with empagliflozin, for a period of 8 weeks. During this time, you will have regular visits to the clinic so doctors can monitor your health and how the treatment is affecting you.
These visits will involve various assessments, including blood tests and measurements of your liver pressure. These measurements are crucial for the researchers to understand if the treatments are working. Doctors will also check for any side effects you might experience.
After the 8-week treatment period, there will be follow-up appointments to ensure your health remains stable and to collect any final information. The total duration you'd be involved in the study, from your first visit to your last, would be explained to you in detail by the study team.
Potential risks and benefits
Locations (9)
- —UnverifiedSpain
- —UnverifiedAustria
- —UnverifiedNetherlands
- —UnverifiedGermany
- —UnverifiedDenmark
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedRomania
Common questions
What is portal hypertension?
It's when you have high blood pressure in the main vein that carries blood to your liver, often due to liver scarring.
What is compensated cirrhosis?
This is a type of liver scarring where your liver is still working well enough, but it can lead to problems like portal hypertension.
What are BI 685509 and empagliflozin?
BI 685509 is an experimental new drug being tested, and empagliflozin is an existing drug used for other conditions, which is also being explored in this study.
How long will the treatment last?
The active treatment period in this study is 8 weeks.
Will I know which treatment I'm getting?
This is an 'open-label' study, which means you and your doctors will know which treatment you are receiving.
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.