RecruitingRare disease

Study of Elafibranor for Adults with Primary Biliary Cholangitis

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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 will test a medication called elafibranor, which is taken as a film-coated tablet. Participants in the study will either receive elafibranor or a placebo tablet, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate how effective and safe elafibranor is for people with PBC. Participants will take the medication daily and will be monitored over a long period to see how it affects their health. The study will look at how long participants remain free from disease progression or other serious health events. It will also track any side effects or changes in health that occur during the study.

Throughout the study, participants will have regular check-ups to monitor their liver function and overall health. This will include physical exams, blood tests, and other assessments to ensure their safety and to gather information on how the treatment is working. The study aims to provide valuable insights into the potential benefits of elafibranor for people living with 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
Randomization and initial assessment
Upon joining the study, participants are randomly assigned to one of two groups: one receiving the elafibranor 80 mg tablet and the other receiving a placebo tablet. This process is double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication.
Participants undergo a comprehensive initial assessment, which includes a complete physical examination, laboratory tests, and an electrocardiogram (ECG) to establish baseline health metrics.
Step 2
Medication administration
Participants take the assigned tablet orally once daily. The dosage for those receiving elafibranor is 80 mg per day.
The treatment period lasts up to 3.5 years, with regular monitoring throughout this time.
Step 3
Regular follow-up visits
Participants attend follow-up visits every six months. During these visits, assessments are conducted to monitor any changes in health status, including physical examinations, laboratory tests, and ECGs.
Specific health parameters such as liver function, lipid levels, and symptoms related to primary biliary cholangitis (PBC) are evaluated.
Step 4
Monitoring of adverse events
Throughout the study, any adverse events or side effects experienced by participants are recorded and assessed. This includes treatment-emergent adverse events, serious adverse events, and any events of special interest.
Participants are encouraged to report any new symptoms or changes in health to the study team during their visits.
Step 5
End of treatment evaluation
At the end of the treatment period, participants undergo a final evaluation. This includes a comprehensive assessment similar to the initial one, focusing on any changes in health status and the overall effectiveness of the treatment.
The study aims to determine the time to occurrence of clinical outcome events and assess the long-term safety and efficacy of elafibranor in treating PBC.

Who can join the trial?

6 criteria

Participants must be male or female and at least 18 years old at the time of signing the informed consent.
Participants must have a definite or probable diagnosis of primary biliary cholangitis (PBC), which is a liver disease.
Participants must have cirrhosis, which is a condition where the liver is scarred and damaged, at the start of the study.
Participants must be classified as Child Pugh A or Child Pugh B, which are categories used to assess the severity of liver disease.
Participants must use contraception methods that follow local regulations for clinical studies.
Participants must be able to give signed informed consent, agreeing to follow the study's requirements and restrictions.

Who cannot join the trial?

10 criteria

Patients who have other serious liver diseases besides Primary Biliary Cholangitis (PBC) cannot participate. PBC is a condition where the bile ducts in the liver are slowly destroyed.
Individuals with severe heart problems are excluded. This means if your heart is not working well, you cannot join.
People with uncontrolled diabetes are not eligible. This means if your blood sugar levels are not stable, you cannot take part.
Participants who have had a liver transplant cannot join the study.
Pregnant or breastfeeding women are not allowed to participate.
Anyone with a history of alcohol or drug abuse in the past year is excluded.
Patients who are currently participating in another clinical trial cannot join this study.
Individuals with certain types of cancer, except for some skin cancers, are not eligible.
People with severe kidney problems are excluded. This means if your kidneys are not working well, you cannot participate.
Anyone with a known allergy to the study medication or similar drugs cannot take part.

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Verified sites

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

Futuremeds Sp. z o.o.
Responsive
Wroclaw, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Responsive
Cracow, Poland
Roskilde University
Responsive
Roskilde, Denmark

Trial locations

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Investigated drugs

Elafibranor is a medication being studied for its potential to improve long-term clinical outcomes in adults with Primary Biliary Cholangitis (PBC). This study aims to determine how effective and safe Elafibranor is when taken daily. The goal is to see if it can help delay or prevent clinical events related to PBC and cirrhosis.

Elafibranor

What is already known about the treatment

Elafibranor – Elafibranor is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating Primary Biliary Cholangitis (PBC), a chronic liver disease. The main therapeutic indication for Elafibranor is to improve long-term clinical outcomes in adults with PBC. At the molecular level, Elafibranor works by activating certain proteins in the body that help regulate lipid and glucose metabolism, as well as inflammation. It is classified pharmacologically as a dual PPAR alpha/delta agonist.

Investigated diseases

Primary Biliary Cholangitis – This is a chronic disease that slowly damages the bile ducts in the liver. Over time, the bile ducts become inflamed and scarred, leading to their gradual destruction. As the bile ducts are damaged, bile builds up in the liver, causing further liver damage. This can eventually lead to cirrhosis, where the liver becomes scarred and loses its ability to function properly. Symptoms often include fatigue, itchy skin, and dry eyes and mouth. The disease progresses slowly, and symptoms may not appear until significant liver damage has occurred.