Not recruitingRare disease

Study on the Effects of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis Who Cannot Tolerate Ursodeoxycholic Acid

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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 liver disease called Primary Biliary Cholangitis (PBC). PBC is a condition where the bile ducts in the liver become damaged, leading to a buildup of bile that can harm the liver. The study is testing the effects of two investigational drugs, obeticholic acid (also known as OCA) and bezafibrate (BZF), to see if they can help people with PBC who have not responded well to or cannot tolerate another treatment called ursodeoxycholic acid.

The purpose of the study is to evaluate how well the combination of OCA and BZF works compared to BZF alone in managing PBC. Participants in the study will receive either the combination of OCA and BZF, BZF alone, or a placebo. The study will last for about 53 weeks, during which participants will take the medication orally in the form of tablets. The researchers will monitor the participants' health and liver function throughout the study to assess the safety and effectiveness of the treatment.

During the study, the main focus will be on measuring changes in a liver enzyme called alkaline phosphatase (ALP), which is often elevated in people with PBC. The study will also look at other liver enzymes and substances in the blood to understand the overall impact of the treatment. The goal is to find out if the combination of OCA and BZF can provide better outcomes for people with PBC compared to BZF alone.

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, the patient is confirmed to have a diagnosis of Primary Biliary Cholangitis (PBC) and meets the necessary criteria, such as age and liver biochemistry values.
The patient must have been taking Ursodeoxycholic Acid (UDCA) for at least 12 months with a stable dose for at least 3 months before the start of the study, or not have taken UDCA for 3 months before the study begins.
Step 2
Randomization and treatment assignment
The patient is randomly assigned to one of the treatment groups in a double-blind manner, meaning neither the patient nor the researchers know which treatment the patient receives.
The treatments involve the use of Obeticholic Acid (OCA) and Bezafibrate (BZF), or a placebo.
Step 3
Medication administration
The patient takes the assigned medication orally. The specific medications include Bezalip (Bezafibrate), Ocaliva 10 mg (Obeticholic Acid), Bezalip Mono (Bezafibrate), and Ocaliva 5 mg (Obeticholic Acid), or their respective placebos.
The medications are administered in the form of film-coated tablets or prolonged-release tablets.
Step 4
Treatment duration
The treatment period lasts for 12 weeks, during which the patient continues to take the assigned medication as instructed.
Step 5
Monitoring and assessments
Throughout the study, the patient's health and response to the medication are monitored. This includes regular assessments of liver function and other relevant health indicators.
The primary focus is on changes in Alkaline Phosphatase (ALP) levels from the start of the study to week 12.
Step 6
Study completion
At the end of the 12-week period, the patient's response to the treatment is evaluated based on the changes in ALP and other health markers.
The study aims to determine the efficacy, safety, and tolerability of the combination of OCA and BZF in patients with PBC.

Who can join the trial?

4 criteria

You must have a definite or probable diagnosis of Primary Biliary Cholangitis (PBC). This is a liver condition that affects the bile ducts.
Your liver test results must show certain levels of alkaline phosphatase (ALP) and/or bilirubin. These are substances measured in blood tests to check liver function.
You must be at least 18 years old.
You should have been taking UDCA (a medication for PBC) for at least 12 months, with a stable dose for at least 3 months before the start of the study. If you are not taking UDCA, you should not have taken it for 3 months before the study begins.

Who cannot join the trial?

8 criteria

Patients who have a different liver condition other than Primary Biliary Cholangitis (PBC) cannot participate. PBC is a disease that affects the bile ducts in the liver.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have participated in another clinical trial recently may not be eligible to participate.
Patients who have allergies or reactions to the study medications cannot participate.
Patients who have a history of alcohol or drug abuse may not be eligible to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
KBC Zagreb
Responsive
Zagreb, Croatia
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

Trial locations

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Investigated drugs

Obeticholic Acid
is a medication used in this trial to help treat primary biliary cholangitis (PBC), a liver disease. It works by reducing inflammation and improving liver function. In this study, it is being tested in combination with another medication to see if it can help patients who have not responded well to other treatments.
Bezafibrate
is another medication used in the trial for treating primary biliary cholangitis. It is known to help lower certain substances in the blood that can cause liver damage. The study is examining how effective it is when used alone and in combination with Obeticholic Acid.
Ursodeoxycholic Acid
is a standard treatment for primary biliary cholangitis. However, some patients do not respond well to it or cannot tolerate it. This trial is focused on finding alternative treatments for those patients.

What is already known about the treatment

Obeticholic Acid
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating Primary Biliary Cholangitis (PBC). It is often used in combination with other medications like Bezafibrate for patients who do not respond well to or cannot tolerate Ursodeoxycholic Acid. Obeticholic Acid works by activating a specific receptor in the liver, which helps reduce liver inflammation and damage. It is classified as a farnesoid X receptor agonist.
Bezafibrate
This medication is also taken orally and is being evaluated in clinical trials for its role in managing Primary Biliary Cholangitis (PBC). It is used in combination with Obeticholic Acid to improve treatment outcomes for patients with inadequate response to standard therapies. Bezafibrate functions by activating certain receptors that help lower lipid levels and reduce liver inflammation. It belongs to the class of medications known as fibrates.

Investigated diseases

Primary Biliary Cholangitis (PBC) – This is a chronic liver disease characterized by the gradual destruction of the bile ducts within the liver. As the bile ducts are damaged, bile builds up in the liver, leading to inflammation and scarring. Over time, this can result in liver damage and impaired liver function. The disease often progresses slowly, and symptoms may include fatigue, itching, and jaundice. The exact cause of PBC is not well understood, but it is believed to involve an autoimmune component. It primarily affects middle-aged women and is considered a rare disease.