Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

The AGAINST-PLD; An investigator-driven, randomized, open label clinical trial assessing efficacy of leuprorelin to halt disease progression in PLD

This study, called 'The AGAINST-PLD', is testing a medicine named leuprorelin for women with polycystic liver disease (PLD). PLD is a condition where many cysts grow in the liver. Researchers want to see if leuprorelin can slow down how fast these cysts grow over 18 months. They will measure liver size using MRI scans and also check how patients’ symptoms, like discomfort, change during the study. This is a Phase 3 study, meaning it is a later stage trial aiming to confirm if the treatment is effective and safe. The goal is to find better ways to manage PLD.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

Start

27 Nov 2024

polycystic liver disease

What is this study about?

This study is looking into a condition called polycystic liver disease, often shortened to PLD. In PLD, many fluid-filled sacs, called cysts, grow in the liver. Over time, these cysts can make the liver grow larger and cause symptoms like discomfort or tummy pain. Currently, there aren't many treatments that directly stop the cysts from growing, so doctors are always looking for better options.

This research is focused on a medicine called leuprorelin. Doctors want to understand if this medicine can help to slow down, or even stop, the growth of these cysts in the liver. If it can, it might help to keep the liver healthier and reduce the symptoms that people with PLD often experience.

To figure this out, scientists will compare two groups of women with PLD. One group will start taking leuprorelin right away, and the other group will start later. By comparing these groups, the researchers can clearly see if the medicine is making a difference. They will carefully check the size of the liver using special scans and also ask about any changes in symptoms over an 18-month period. This kind of study, known as a Phase 3 trial, is a very important step to see if a new treatment should be made available more widely.

Key takeaways

Tests a new medicine (leuprorelin) for polycystic liver disease (PLD).
Aims to slow down liver cyst growth and improve symptoms.
Specifically for women aged 18 and over with PLD.
Involves regular MRI scans and symptom questionnaires over 18 months.
May offer early access to a new treatment option.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is specifically looking for women who have polycystic liver disease (PLD) and are aged 18 or older. There is no upper age limit, meaning women of any adult age can potentially take part.

It's important to note that this study is only for women, as the medicine being tested, leuprorelin, affects hormones that are particularly relevant to women's health.

If you are a woman with PLD and are over 18, you might be a good fit for this study. However, the study doctors will go through a full check-up to make sure it's safe and suitable for you.

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 a woman?
Are you 18 years old or older?
Have you been diagnosed with polycystic liver disease (PLD)?
Are you willing to have regular MRI scans and attend appointments for 18 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two groups. One group will start the study medicine (leuprorelin) right away, and the other group will start it after a few months. This is to help the researchers compare the effects of the medicine fairly.

You will have several visits to the hospital or clinic over 18 months. During these visits, you will have regular MRI scans to measure your liver size and see how the cysts are changing. You will also be asked to fill out questionnaires about your symptoms and how you are feeling, which helps the doctors understand the impact of PLD on your daily life. The study will also carefully monitor you for any side effects from the medicine. After the 18 months, there will be follow-up appointments to check on your health.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new treatment that might help slow down the progression of polycystic liver disease and reduce your symptoms, which are not always well-controlled with current options. However, as with any medicine, leuprorelin can have side effects, which the study team will discuss with you. There's also the chance the treatment may not work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is polycystic liver disease (PLD)?

PLD is a condition where many fluid-filled sacs, called cysts, grow in your liver, which can make it larger and cause symptoms.

What is leuprorelin?

Leuprorelin is a medicine being tested in this study to see if it can slow down the growth of cysts in the liver.

Why are only women included in this study?

This study focuses on women because the medicine being tested affects hormones that are particularly relevant to women's health in relation to PLD.

How long does the study last?

The main treatment and assessment period for this study is 18 months, with follow-up appointments afterwards.

Will I have to pay to be part of the study?

No, you will not have to pay to participate in the study, and all study-related treatments and tests are provided free of charge.