Study on Leuprorelin Acetate for Slowing Disease Progression in Premenopausal Women with Severe Polycystic Liver Disease

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What is this study about?

This clinical trial is focused on studying polycystic liver disease, a condition where multiple cysts form in the liver, causing it to enlarge. The treatment being tested is called leuprorelin acetate, which is a medication that helps lower certain hormone levels in the body. The purpose of the study is to see if this treatment can slow down the growth of the liver in women who have this disease.

Participants in the study will be divided into two groups. One group will start receiving the treatment right away, while the other group will have a delayed start. The study will last for 18 months, during which the growth of the liver will be monitored using MRI scans. The study aims to compare the liver growth rates between the two groups to determine the effectiveness of the treatment.

Throughout the study, researchers will also keep track of any symptoms related to polycystic liver disease and any side effects that may occur. This information will help in understanding how the treatment affects the participants’ overall health and well-being. The study is designed to provide valuable insights into managing polycystic liver disease and improving treatment options for those affected by it.

1 initial assessment

Upon joining the study, you will undergo an initial assessment. This includes a review of your medical history and a physical examination to confirm your eligibility for the trial.

You will be asked to provide written consent to participate in the study. This consent confirms that you understand the trial procedures and agree to take part.

2 randomization

You will be randomly assigned to one of two groups: the direct start group or the delayed start group. This process is like flipping a coin to decide which group you will join.

The direct start group will begin treatment immediately, while the delayed start group will begin treatment after a specified period.

3 treatment administration

If you are in the direct start group, you will receive the medication leuprorelin acetate as a subcutaneous injection. This means the medication is injected under the skin.

The dosage and frequency of the injections will be explained to you by the study team. The treatment will last for 18 months.

4 regular monitoring

Throughout the trial, you will have regular check-ups to monitor your health and the effects of the treatment. This includes measuring liver growth rates using MRI scans.

You will also be asked to complete questionnaires about any symptoms or side effects you experience.

5 end of treatment evaluation

At the end of the 18-month treatment period, you will undergo a final evaluation. This includes a physical examination and MRI scans to assess liver growth.

You will also complete a final questionnaire to provide feedback on your experience during the trial.

Who Can Join the Study?

Must be a female patient.
Age must be between 18 to 45 years old.
Must have a very large liver for your age. This means your liver size is in the top 10% for your age group. The specific measurements are:
- For ages 18-30: liver volume greater than 2.0 liters per meter of height.
- For ages 30-35: liver volume greater than 2.2 liters per meter of height.
- For ages 35-40: liver volume greater than 2.5 liters per meter of height.
- For ages 40-45: liver volume greater than 3.0 liters per meter of height.
- Or, regardless of age, liver volume greater than 2.0 liters per meter of height and a PLD-Q score over 30.
Regarding the use of somatostatin analogues (a type of medication):
- You are using this medication but your liver is still growing.
- Or, you have a reason not to use this medication, such as:
  - You used it before but it didn’t work or you couldn’t tolerate it.
  - You have a medical reason not to use it.
  - You or your doctor decided not to try it.
  - The medication is not available to you.
Must provide voluntary written consent before any study-related procedures that are not part of standard medical care. You must be able to read, understand, and answer study questionnaires.
Must have a diagnosis of polycystic liver disease, which means having more than 10 liver cysts.

Who Cannot Join the Study?

Patients who are not female cannot participate.
Patients who are not pre-menopausal cannot participate. Pre-menopausal means women who have not yet gone through menopause, which is when menstrual periods stop permanently.
Patients who do not have severe polycystic liver disease cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Undakmderjfk Myzipbo Cxvhkab Gomckzfzd	Groningen	The Netherlands
Aqpisllua Urk	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.10.2024

Trial locations

Investigated drugs:

Leuprorelin Acetate

Leuprorelin is a medication used in this clinical trial to help manage polycystic liver disease. It works by lowering the levels of certain hormones in the body, specifically estrogen and progesterone. By reducing these hormone levels, the medication aims to slow down the growth of liver cysts in women who have not yet gone through menopause. The trial is designed to see if starting treatment with leuprorelin right away is more effective than delaying the start of treatment. Participants will receive this medication over a period of 18 months to assess its impact on the progression of their liver disease.

Investigated diseases:

Polycystic liver disease

Polycystic liver disease – Polycystic liver disease is a genetic condition characterized by the development of numerous fluid-filled cysts in the liver. These cysts can vary in size and number, leading to an increase in liver volume over time. The disease progresses as the cysts grow and multiply, which can cause the liver to enlarge significantly. This enlargement may lead to discomfort or pain in the abdomen due to the increased size of the liver. As the liver grows, it can also affect the function of nearby organs by exerting pressure on them. The progression of the disease is typically slow, and the severity can vary widely among individuals.

Trial ID:

2023-506637-30-00

Protocol code:

202000894

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Leuprorelin Acetate for Slowing Disease Progression in Premenopausal Women with Severe Polycystic Liver Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?