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Study on Bezafibrate for Patients with Primary Sclerosing Cholangitis and Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy

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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 medication called bezafibrate in patients with a liver disease known as Primary Sclerosing Cholangitis (PSC). PSC is a condition where the bile ducts, which carry digestive fluid from the liver to the small intestine, become inflamed and scarred, leading to liver damage. The study is specifically looking at patients who continue to have a condition called cholestasis, which is a reduction or stoppage of bile flow, despite being treated with a standard medication called ursodeoxycholic acid (UDCA).

The purpose of the study is to evaluate the effectiveness of bezafibrate over a period of 24 months. Participants in the study will be randomly assigned to receive either bezafibrate or a placebo, in addition to their usual UDCA treatment. A placebo is a substance with no active medication, used to compare the effects of the actual drug. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving bezafibrate and who is receiving the placebo, to ensure unbiased results.

Throughout the study, participants will continue their regular medical care and will have periodic check-ups to monitor their health and the effects of the treatment. The study aims to see if bezafibrate can help improve liver function and reduce symptoms in patients with PSC. The trial will last for two years, and participants will be closely monitored for any changes in their condition and overall health.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed through signed informed consent. Eligibility is based on specific criteria, including age between 18 and 75 years, diagnosis of primary sclerosing cholangitis (PSC), and previous treatment with ursodeoxycholic acid (UDCA) for at least six months.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either bezafibrate or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

  3. Step 3

    Medication administration

    The treatment involves taking a 400 mg prolonged-release tablet of bezafibrate or a placebo once daily. This is in addition to the standard UDCA therapy.

  4. Step 4

    Treatment duration

    The treatment period lasts for 24 months. During this time, regular monitoring and assessments are conducted to evaluate the treatment's effectiveness and safety.

  5. Step 5

    Monitoring and assessments

    Throughout the trial, various health parameters are monitored. These include serum alkaline phosphatase levels, liver stiffness, and overall liver function. Quality of life and symptoms such as itching and fatigue are also assessed using specific questionnaires.

  6. Step 6

    End of trial

    At the end of the 24-month period, final assessments are conducted to determine the treatment's impact on the condition. The primary goal is to see if there is a significant improvement in liver function and symptom management.

Who can join the trial?

8 criteria

  • Men or women who are at least 18 years old and no older than 75 years.
  • Have a condition called **primary sclerosing cholangitis (PSC)**, which affects the bile ducts, confirmed by specific imaging tests like **magnetic resonance cholangiography (MRC)**.
  • Have had a **colonoscopy** (a test to look inside the colon) within the last 5 years, or within 6 months if they also have **inflammatory bowel disease (IBD)** with PSC, showing no cancer or abnormal cell growth. If they have had surgery connecting the small intestine to the anus, they need an endoscopy of this area within the last 2 years.
  • Have a blood test result called **ALP** that is at least 1.5 times the upper limit of normal.
  • Have been taking a medication called **UDCA** at a dose of 13-23 mg per kg of body weight per day for at least 6 months before joining the study.
  • Women who can have children must use a reliable form of birth control to prevent pregnancy.
  • Must be part of a social security system, except for a specific type called AME.
  • Must have signed a document agreeing to participate in the study after being informed about it.

Who cannot join the trial?

7 criteria

  • Patients who are not diagnosed with primary sclerosing cholangitis cannot participate. This is a liver disease that affects the bile ducts.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
  • Patients who are not able to take the study medication or follow the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
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Investigated drugs

  • Bezafibrate

    is a medication being tested in this trial for its effectiveness in treating primary sclerosing cholangitis, a liver disease. It is being studied to see if it can help improve liver function in patients who have not responded well to standard treatment.

  • Ursodeoxycholic Acid (UDCA)

    is a standard therapy used in the treatment of primary sclerosing cholangitis. It helps to improve liver function and reduce liver damage. In this trial, it is used as a part of the standard treatment regimen.

What is already known about the treatment

Bezafibrate – Bezafibrate is administered orally in the form of sustained-release tablets, typically at a dose of 400 mg per day. It is currently being studied in clinical trials for its effectiveness in treating primary sclerosing cholangitis, a liver disease, especially in patients who do not respond well to standard ursodeoxycholic acid therapy. The medication works by activating certain receptors in the liver, which helps to reduce bile acid levels and improve liver function. Bezafibrate is classified as a fibrate, a type of medication primarily used to lower cholesterol and triglyceride levels in the blood.

Investigated diseases

Primary Sclerosing Cholangitis – This is a chronic liver disease characterized by inflammation and scarring of the bile ducts, which can lead to blockages. Over time, these blockages can cause bile to accumulate in the liver, resulting in liver damage. The disease progresses slowly and can lead to liver cirrhosis or liver failure if untreated. Symptoms may include fatigue, itching, and jaundice, although some individuals may not experience noticeable symptoms in the early stages. The exact cause of primary sclerosing cholangitis is unknown, but it is often associated with inflammatory bowel diseases. The progression of the disease varies among individuals, with some experiencing a more rapid decline in liver function than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511658-28-01Protocol codeAPHP180668Estimated enrolment130 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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