Not recruitingRare disease

Study on Maralixibat Chloride for Treating Itchy Skin in Patients with Cholestatic Pruritus

Verified siteInvestigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for cholestatic pruritus, a condition characterized by severe itching due to liver problems. The treatment being tested is called Maralixibat chloride, which is taken as an oral solution. This medication works as an ileal bile acid transporter (IBAT) inhibitor, which means it helps to reduce the amount of bile acids in the body that can cause itching.

The purpose of the study is to evaluate how effective Maralixibat chloride is compared to a placebo in reducing the severity of itching in participants with cholestatic pruritus. Participants in the study will be randomly assigned to receive either the medication or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. The study will last for a period of 40 weeks, during which participants will take the oral solution and attend regular study visits to monitor their condition and any changes in their symptoms.

Throughout the study, participants will be asked to report on their itching symptoms using a tool called the Itch-Reported Outcome (ItchRO), which helps to measure the severity of their itching. The study aims to see if there is a significant improvement in the itching symptoms of those taking Maralixibat chloride compared to those taking the placebo. This research is important for finding better ways to manage and treat the discomfort associated with cholestatic pruritus.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the details of the study.
You will need to confirm your willingness to attend all study visits and meet the requirements until the end of the study.
Step 2
Baseline visit
At the baseline visit, your eligibility will be confirmed. This includes having a diagnosis of cholestatic pruritus and meeting other criteria such as age and health status.
You will be required to complete daily entries about your itch severity using a tool called ItchRO for two consecutive weeks before starting the study medication.
Step 3
Medication administration
You will be randomly assigned to receive either maralixibat chloride or a placebo. Both are given as an oral solution.
The medication will be taken as directed by the study team, and you will continue this regimen for the duration of the study.
Step 4
Ongoing assessments
Throughout the study, you will have regular visits to monitor your health and the effects of the medication.
You will continue to record your itch severity using the ItchRO tool, which helps track changes over time.
Step 5
End of the trial
At the end of the study, your participation will be concluded, and you will have a final assessment to evaluate the overall impact of the treatment.
You may be asked to provide feedback on your experience during the trial.

Who can join the trial?

10 criteria

Provide informed consent and assent if applicable. This means you agree to participate after understanding the study details.
Be willing (you or your caregiver) to attend all study visits and follow the study requirements until it ends.
Be at least 6 months old at the time of the first visit.
Have a diagnosis of cholestatic liver disease with cholestatic pruritus. This includes having abnormal liver tests for more than 90 days or evidence of liver disease, and having persistent itching for more than 90 days.
Complete at least 10 valid daily entries about your itching during the 2 weeks before the first visit.
If you are taking medications for itching or liver disease, you must have been on a stable dose for at least 30 days before the first visit and continue this dose during the study.
If you are a female who can become pregnant and are sexually active, you must agree to use an acceptable method of birth control during the study and for 30 days after the last dose of the study drug. You must also have a negative pregnancy test result.
Have access to email or telephone for scheduled contacts and a smartphone or tablet for completing questionnaires.
Be able to read and understand the questionnaires if you are 9 years or older, or have a caregiver who can do so.
If you are 18 years or younger, have access to a consistent caregiver during the study.

Who cannot join the trial?

9 criteria

Patients who are not experiencing cholestatic pruritus cannot participate. Cholestatic pruritus is severe itching due to liver problems.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who are not willing to follow the study procedures cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are taking medications that might affect the study results cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently cannot participate.
Patients who have a history of drug or alcohol abuse cannot participate.
Patients who have a known allergy to the study medication cannot participate.

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Verified sites

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Azienda Ospedaliera Papa Giovanni XXIII
Verified
Bergamo, Italy
Bicetre Hospital
Verified
Le Kremlin-Bicetre, France
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

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Investigated drugs

Maralixibat is a medication being studied for its potential to help people who experience severe itching due to a liver condition called cholestatic pruritus. This medication works by blocking a specific protein in the body that is involved in the process that causes itching. By doing this, maralixibat aims to reduce the intensity and frequency of the itching, improving the comfort and quality of life for those affected by this condition.

Maralixibat Chloride

What is already known about the treatment

Maralixibat – Maralixibat is administered orally, typically in the form of a liquid solution. It is currently being studied in a Phase 3 clinical trial to assess its effectiveness and safety for treating cholestatic pruritus, a condition characterized by severe itching due to liver disease. The medication works by blocking certain transporters in the liver and intestines, which helps reduce the buildup of bile acids that cause itching. Maralixibat is classified as an ileal bile acid transporter inhibitor, and its main therapeutic use is aimed at alleviating symptoms of pruritus associated with liver conditions.

Investigated diseases

Cholestatic Pruritus – Cholestatic pruritus is a condition characterized by intense itching due to impaired bile flow in the liver. This itching is often widespread and can be more severe at night. The condition is associated with liver diseases where bile acids accumulate in the bloodstream. As the disease progresses, the itching can become more persistent and may affect daily activities. The severity of the itching can vary, and it may be accompanied by other symptoms of liver dysfunction. The exact cause of the itching is not fully understood, but it is believed to be related to the accumulation of bile acids and other substances in the skin.