A Two Part Phase IIa/b Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Dose ranging Study to Assess Efficacy, Safety, and Tolerability of the Combination of Zibotentan and Dapagliflozin, and Dapagliflozin Monotherapy Versus Placebo in Participants with Cirrhosis with Features of Portal Hypertension
This research study is investigating new treatments for people with liver scarring, known as cirrhosis, which is causing high blood pressure in the main vein leading into the liver (portal hypertension). We are testing a combination of two different medicines, Zibotentan and Dapagliflozin, to see if they can effectively lower this pressure. We are also comparing this combination to Dapagliflozin by itself, and to a 'dummy pill' (placebo) that contains no active medicine. The main goal is to find out if these treatments are safe and if they can reduce the pressure in the liver vein. We'll be carefully watching how participants respond over six weeks, and in some cases, up to sixteen weeks, looking at various health markers like weight and blood pressure.
At a glance
What is this study about?
This study is about helping people who have scarring of the liver, called cirrhosis. When the liver becomes scarred, it can make it harder for blood to flow through it, which then causes high pressure in the main vein that carries blood to the liver. This high pressure is called portal hypertension. This condition can lead to serious health problems.
We are exploring new ways to treat this high pressure. The study is looking at two medicines, Zibotentan and Dapagliflozin. We want to see how well they work together, and also how Dapagliflozin works on its own, compared to a dummy pill that contains no medicine. The main thing we’ll be checking is if these treatments can lower the pressure in the liver vein. We'll be measuring this pressure at the start and then again after six weeks.
We also want to make sure the treatments are safe and well-tolerated by participants. Besides checking the liver pressure, we'll be looking at other important health aspects like changes in body weight, how much water the body holds, blood pressure, and how much diuretic (water pill) medicine participants might need. This will help us get a full picture of how these new treatments affect people with liver cirrhosis and portal hypertension.
Key takeaways
- This study is for adults with liver scarring and high pressure in their liver's main vein.
- It tests new medicines (Zibotentan and Dapagliflozin) to lower this liver pressure.
- You might receive one medicine, a combination, or a dummy pill.
- Participation involves clinic visits and careful health monitoring for about 6-16 weeks.
- The aim is to find safer and more effective ways to treat this serious liver condition.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part.
The study is specifically for people who have been diagnosed with liver cirrhosis and are experiencing features of high blood pressure in the main blood vessel leading to their liver. If you're unsure if this describes your condition, your doctor can help clarify.
There might be other health conditions or medications that would prevent someone from joining, even if they meet these basic requirements. The study doctors will carefully review your full medical history to make sure it's safe for you to participate.
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 or older?
- Do you have liver scarring (cirrhosis)?
- Have your doctors told you that you have high pressure in your liver's blood vessels (portal hypertension)?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you decide to take part in this study, you will be assigned to one of three groups by chance, like flipping a coin, so neither you nor the doctors will know which treatment you are receiving (this is called 'double-blind'). You might receive the combination of Zibotentan and Dapagliflozin, Dapagliflozin alone, or a dummy pill (placebo).
You will need to attend several appointments at the study clinic. These visits will involve various health checks, including blood tests, physical examinations, and special measurements to check your liver pressure at the beginning and again after six weeks. Some measurements, like your weight, might be taken at home and at the clinic. We will also monitor your blood pressure and look at how your body handles fluids.
The treatment period for the main part of the study is six weeks. For some participants, we will continue to monitor certain health markers for up to sixteen weeks. You will receive all study medication from the clinic.
Potential risks and benefits
Locations (9)
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- —UnverifiedDenmark
- —UnverifiedAustria
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedCzechia
- —UnverifiedRomania
Common questions
What is liver cirrhosis?
Liver cirrhosis is a serious scarring of the liver which can stop it from working properly.
What is portal hypertension?
Portal hypertension means there is high blood pressure in the main vein that carries blood to your liver, often caused by cirrhosis.
What is a 'dummy pill' (placebo)?
A dummy pill looks like the study drug but contains no active medicine. It helps us see if the new medicine is truly effective compared to receiving no treatment.
How long will I be in the study?
The main treatment part of the study lasts for six weeks, with some follow-up monitoring for up to sixteen weeks in total.
Can I leave the study early if I want to?
Yes, you are free to leave the study at any time, for any reason, without affecting your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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