Study on Octreotide for Patients with Symptomatic Polycystic Liver Disease

4 1 1

What is this study about?

This clinical trial is focused on studying polycystic liver disease, a condition where multiple cysts form in the liver, leading to symptoms like bloating, abdominal discomfort, and pain. The trial will evaluate a treatment called CAM2029 (octreotide subcutaneous depot), which is administered as an injection under the skin. The purpose of the study is to assess the effectiveness and safety of this treatment in reducing liver volume in patients with this condition.

Participants in the trial will receive either the CAM2029 treatment or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This approach helps ensure unbiased results. The trial will take place over a period of time, with regular check-ups and assessments to monitor changes in liver size and symptoms.

Throughout the study, participants will undergo various evaluations, including MRI scans to measure liver volume and assessments of symptom changes. The trial aims to provide valuable information on how CAM2029 can potentially benefit those with polycystic liver disease, offering insights into its impact on liver size and overall health. Participants’ safety and well-being will be closely monitored throughout the trial period.

1 joining the trial

Upon joining the trial, you will provide a written informed consent. This confirms your voluntary participation and understanding of the trial procedures.

2 initial assessment

You will undergo an initial assessment to confirm your eligibility. This includes verifying your diagnosis of polycystic liver disease and checking for specific symptoms such as bloating, abdominal fullness, or pain.

3 randomization

You will be randomly assigned to receive either the trial medication, CAM2029 (octreotide subcutaneous depot), or a placebo. This process is double-blind, meaning neither you nor the trial staff will know which treatment you are receiving.

4 treatment administration

You will receive the treatment as a subcutaneous injection. The frequency and dosage will be determined by the trial protocol and communicated to you by the trial staff.

5 regular monitoring

Throughout the trial, you will have regular appointments to monitor your health and the effects of the treatment. This includes magnetic resonance imaging (MRI) to measure changes in liver volume and other health assessments.

6 end of treatment evaluation

At the end of the treatment period, which lasts up to 53 weeks, you will undergo a final evaluation. This will assess changes in your liver volume and any symptoms you may have experienced.

7 follow-up

After completing the trial, there may be follow-up visits to monitor your health and gather additional data on the long-term effects of the treatment.

Who Can Join the Study?

The patient must provide voluntary and valid written informed consent to participate in the trial before any trial-related procedures are performed.
The patient must be male or female and at least 18 years old at the time of screening.
The patient must have a diagnosis of polycystic liver disease, which can be associated with a condition called ADPKD or be isolated as in ADPLD, with a liver volume of at least 1800 ml/m at the time of screening.
The patient must have at least one of the following symptoms related to polycystic liver disease within two weeks before screening: bloating, feeling full in the abdomen, lack of appetite, feeling full quickly after starting to eat, acid reflux, nausea, pain or pressure in the rib cage, side pain, abdominal pain, back pain, shortness of breath after physical activity, limited mobility, concern about abdominal enlargement, dissatisfaction with the size of the abdomen.
The patient must not be a candidate for, or not willing to undergo, surgical intervention for liver cysts during the trial.
Female patients who can have children must be willing to use an acceptable method of contraception from screening and during the entire trial.
Male patients must be willing to use a condom as a method of contraception from screening and throughout the trial unless they have been sterilized by a procedure called vasectomy (with appropriate documentation showing the absence of sperm in the ejaculate).

Who Cannot Join the Study?

Patients who have a different liver condition other than polycystic liver disease cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaet Leipzig	Leipzig	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Medizinische Hochschule Hannover	Hanover	Germany

Other Sites

Site Name	City	Country	Status
Westfaelische Wilhelms Universitaet Muenster	Munster	Germany
Styioeqxl Roafhzp Ubifjgfdnn Mpyvgmc Cgcgea	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	14.10.2022
Germany	Not recruiting	14.10.2022
The Netherlands	Not recruiting	14.10.2022

Trial locations

Investigated drugs:

Octreotide Hydrochloride

Octreotide subcutaneous depot (CAM2029) is a medication used in this clinical trial to help manage symptoms of polycystic liver disease. It is designed to be injected under the skin and works by mimicking a natural hormone in the body called somatostatin. This hormone helps to reduce the growth of certain types of cells and fluids, which can help decrease the size of the liver and improve symptoms in patients with this condition. The goal of using this medication in the trial is to see if it can effectively reduce liver volume and improve the quality of life for patients with polycystic 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. As the cysts grow, they may cause the liver to enlarge, potentially resulting in discomfort or pain in the abdomen. The progression of the disease can lead to changes in liver function, although the liver often continues to work normally for many years. The condition is often associated with polycystic kidney disease, where similar cysts form in the kidneys. The growth of cysts in the liver is typically slow, and symptoms may not appear until later in life.

Trial ID:

2023-505313-24-00

Protocol code:

HS-20-677

NCT ID:

NCT05281328

Trial Phase:

Therapeutic use (Phase IV)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Octreotide for Patients with Symptomatic Polycystic Liver Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?