Not recruitingRare disease

Study on Volixibat for Treating Itching in Patients with Primary Biliary Cholangitis

Fast replyInvestigationalNo placebo

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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 a condition called Primary Biliary Cholangitis (PBC), which is a liver disease that can cause severe itching, known as cholestatic pruritus. The trial is testing a new treatment called volixibat, which is taken as a hard capsule by mouth. The purpose of the study is to evaluate how effective and safe volixibat is in reducing the itching associated with PBC.

Participants in the study will be randomly assigned to receive either volixibat or a placebo, which looks like the treatment but does not contain the active substance. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The study will last for a period of up to 124 days, during which participants will take the medication daily and attend regular check-ups to monitor their condition and any changes in their symptoms.

The main goal is to see if volixibat can reduce the itching experienced by patients with PBC, as measured by a tool called the Adult ItchRO. Additionally, the study will look at other health indicators, such as changes in certain blood levels and overall quality of life. Participants will be closely monitored for any side effects or adverse reactions to the treatment. The results of this study could provide valuable information about a new potential treatment option for those suffering from PBC-related itching.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will provide signed informed consent. This means you agree to participate and understand the study requirements.
You must be at least 18 years old and have a confirmed diagnosis of primary biliary cholangitis (PBC).
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your condition. This includes measuring your itch levels using the Adult ItchRO tool, which is a way to track your itching symptoms.
Step 3
Medication administration
You will be randomly assigned to receive either the investigational drug volixibat or a placebo. A placebo is a substance with no active medication, used to compare effects.
The medication will be in the form of a hard capsule taken orally. The dosage and frequency will be determined by the study team.
Step 4
Ongoing monitoring
Throughout the study, your itch levels will be monitored regularly using the Adult ItchRO tool.
Additional assessments will include measuring changes in bile acid levels, bilirubin levels, and alkaline phosphatase (ALP) levels, which are indicators of liver function.
Step 5
Quality of life assessments
Your quality of life will be assessed using the Primary Biliary Cholangitis Quality of Life Measure (PBC-40) and the Patient-Reported Outcomes Measurement Information System (PROMIS) for fatigue and sleep.
Step 6
Completion of study
At the end of the study, the mean change in your itch score from the beginning to the end will be evaluated.
The study will also assess any adverse events or side effects experienced during the trial.

Who can join the trial?

5 criteria

Provide signed informed consent at the screening visit and agree to follow all study visits and requirements until the end of the study.
Be a male or female who is at least 18 years old at the time of the screening visit.
Have a confirmed diagnosis of Primary Biliary Cholangitis (PBC) according to the guidelines of the American Association for the Study of Liver Diseases (AASLD).
Use of UDCA (a medication for liver disease) and anti-itch medication is allowed if certain additional criteria are met.
Experience itching (pruritus) associated with PBC, as measured by the Adult ItchRO tool, which is a way to assess itching severity.

Who cannot join the trial?

10 criteria

Patients who have a different type of liver disease other than Primary Biliary Cholangitis (PBC).
Patients who are currently experiencing a severe infection.
Patients who have a history of cancer within the last 5 years, except for certain skin cancers.
Patients who have had a liver transplant or are on a waiting list for one.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy to the study medication or similar drugs.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of drug or alcohol abuse within the last year.
Patients who have a mental health condition that might affect their ability to participate in the study.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified sites

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Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

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Investigated drugs

Volixibat is a medication being studied for its potential to help people with a liver condition called Primary Biliary Cholangitis (PBC) who experience severe itching, known as pruritus. This medication works by targeting a specific process in the body that is believed to contribute to the itching sensation. By interfering with this process, Volixibat aims to reduce the intensity of the itch, providing relief to patients who suffer from this uncomfortable symptom. The study is designed to compare the effects of Volixibat to a placebo, which is a substance with no active ingredients, to see if Volixibat is effective in reducing itching in patients with PBC.

Volixibat

What is already known about the treatment

Volixibat – Volixibat is administered orally in the form of a pill and is currently being studied in clinical trials for its effectiveness and safety in treating itching associated with a liver condition called Primary Biliary Cholangitis (PBC). This medication is not yet widely used in medicine, as it is still under investigation. The main purpose of Volixibat is to help reduce itching in people with PBC. It works by blocking certain proteins in the liver that are involved in bile acid transport, which can help decrease the buildup of substances that cause itching. Volixibat is classified as a bile acid transporter inhibitor.

Investigated diseases

Primary Biliary Cholangitis – Primary Biliary Cholangitis is a chronic disease that slowly destroys the bile ducts in the liver. As the bile ducts are damaged, bile builds up in the liver, leading to inflammation and scarring. Over time, this can cause liver function to decline. One of the symptoms associated with this condition is pruritus, or itching, which can be severe. The disease progresses gradually, and the damage to the liver can lead to further complications. The exact cause of the disease is not well understood, but it is believed to involve an autoimmune response.