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Study on the Effects of Bezafibrate and Obeticholic Acid for Patients with Primary Biliary Cholangitis

Verified siteRegistered drugNo 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 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. The purpose of the study is to assess how well these drugs work together in reducing a liver enzyme called alkaline phosphatase (ALP), which is often elevated in people with PBC.

Participants in the study will be randomly assigned to receive either the combination of OCA and BZF or BZF alone. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are unbiased. The study will last for several weeks, during which participants will take the medication in the form of tablets by mouth. Regular check-ups will be conducted to monitor the participants' health and the effects of the treatment.

The main goal is to observe changes in ALP levels from the start of the study to the end of the treatment period. Additionally, the study will look at other health markers, such as liver function tests and lipid levels, to evaluate the safety and tolerability of the treatment. The results will help determine if the combination of OCA and BZF is more effective than BZF alone in managing PBC.

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
Joining the study
Upon joining the study, participation is confirmed based on a diagnosis of primary biliary cholangitis (PBC) and specific liver biochemistry values.
Eligibility requires either taking ursodeoxycholic acid (UDCA) for at least 12 months or not taking UDCA for 3 months before the start of the study.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline levels of alkaline phosphatase (ALP) and other liver enzymes.
This assessment helps in evaluating the effects of the treatment over the course of the study.
Step 3
Treatment phase
Participants receive a combination of the investigational drugs obeticholic acid (OCA) and bezafibrate (BZF), or BZF alone.
The medication is administered orally in the form of tablets.
The primary goal is to assess the change in ALP levels from the start of the study to Week 12.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to evaluate the safety and tolerability of the treatment.
Response rates and normalization of liver enzyme levels are assessed at Week 12.
Changes in other liver-related markers and lipid levels are also monitored.
Step 5
Completion of study
The study is expected to conclude by March 21, 2025.
Final assessments are made to determine the overall efficacy and safety of the treatment.

Who can join the trial?

5 criteria

Must have a confirmed or likely diagnosis of primary biliary cholangitis (PBC), which is a liver condition.
Must have specific levels of certain liver chemicals, known as alkaline phosphatase (ALP) and bilirubin, which are used to check liver health.
Must have been taking a medication called ursodeoxycholic acid (UDCA) for at least 12 months, or not taking UDCA for at least 3 months before the start of the study.
Both men and women can participate.
Participants can be from a vulnerable population, which means they might need extra protection or care.

Who cannot join the trial?

8 criteria

Patients who have other serious liver diseases besides Primary Biliary Cholangitis (PBC). PBC is a condition where the bile ducts in the liver are slowly destroyed.
Patients who have had a liver transplant.
Patients with severe heart problems.
Patients with severe kidney problems.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients who have a history of alcohol or drug abuse.
Patients who have any condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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Azienda Unita Sanitaria Locale Di Bologna
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Bologna, Italy

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Investigated drugs

Bezafibrate
is a medication used to help lower cholesterol and triglyceride levels in the blood. In this clinical trial, it is being tested to see how well it works in combination with another medication for treating primary biliary cholangitis, a liver disease.
Obeticholic Acid
is a medication used to treat certain liver conditions, including primary biliary cholangitis. In this study, it is being combined with Bezafibrate to evaluate if the combination is more effective in managing the disease compared to using Bezafibrate alone.

What is already known about the treatment

Bezafibrate
Bezafibrate is taken orally and is currently being studied in combination with another medication for its effects on primary biliary cholangitis, a liver disease. It is known for its ability to lower lipid levels in the blood. Bezafibrate works by activating certain receptors in the body that help break down fats, which can improve liver function in some conditions. It is classified as a fibrate, a type of medication used to manage cholesterol and triglyceride levels.
Obeticholic Acid
Obeticholic Acid is administered orally and is being evaluated in combination with Bezafibrate for its potential benefits in treating primary biliary cholangitis. This medication is already recognized for its role in managing this liver condition. It functions by activating specific receptors that reduce bile acid production and improve liver health. Obeticholic Acid is classified as a bile acid analog, which helps in managing liver diseases by modifying bile acid composition.

Investigated diseases

Primary biliary cholangitis – This is a chronic disease that affects the liver, causing inflammation and damage to the bile ducts. Over time, the bile ducts become scarred and blocked, leading to a buildup of bile in the liver. This can result in liver damage and eventually liver failure if not managed. The disease progresses slowly, often over many years, and symptoms may include fatigue, itching, and jaundice. As the condition advances, individuals may experience complications related to liver function. The exact cause of primary biliary cholangitis is not fully understood, but it is believed to involve an autoimmune response.