Study on Elafibranor for Patients with Primary Biliary Cholangitis Not Responding to Ursodeoxycholic Acid

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What is this study about?

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 a medication called elafibranor, which is taken as a film-coated tablet. The purpose of the study is to evaluate the effectiveness and safety of elafibranor in patients with PBC who have not responded well to or cannot tolerate a common treatment called ursodeoxycholic acid.

Participants in the study will be randomly assigned to receive either elafibranor or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for a total of 52 weeks, during which the effects of the treatment on the liver will be closely monitored. After this period, there will be an option for participants to continue in an open-label extension, where everyone will receive elafibranor, to further assess its long-term safety and benefits.

The study aims to see if elafibranor can help reduce the levels of certain liver enzymes and improve symptoms such as itching, which is common in PBC. Participants will have regular check-ups and tests to monitor their liver function and overall health throughout the study. This research hopes to provide new insights into managing PBC and improving the quality of life for those affected by this condition.

1 Joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Written informed consent is required to participate.

Eligibility criteria include being between 18 to 75 years old, having a diagnosis of primary biliary cholangitis, and meeting specific medical conditions.

2 Initial assessment

An initial assessment will be conducted to confirm eligibility. This may include medical history review, physical examination, and laboratory tests.

Patients may need to provide liver biopsy samples if no recent biopsy is available.

3 Randomization and treatment

Patients will be randomly assigned to receive either elafibranor 80 mg or a placebo. The medication is administered orally as a film-coated tablet.

The treatment will last for 52 weeks, with daily administration of the assigned medication.

4 Monitoring and follow-up

Regular follow-up visits will be scheduled to monitor the patient’s health and response to treatment. These visits may include physical exams, blood tests, and assessments of symptoms such as itching.

Patients will be evaluated for changes in liver function and other health markers at specified intervals throughout the study.

5 Completion of treatment phase

At the end of the 52-week treatment period, a final assessment will be conducted to evaluate the response to the medication.

Patients may be asked to provide another liver biopsy sample to assess changes in liver condition.

6 Open-label extension

After completing the initial treatment phase, patients may have the option to participate in an open-label extension where all participants receive elafibranor.

This phase aims to evaluate the long-term safety and efficacy of the medication.

Who Can Join the Study?

Must have provided written informed consent and agree to follow the study rules.
If taking medications called statins or ezetimibe, the dose must be stable for at least 2 months before starting the study.
Females must either not be able to have children or use very effective birth control during the study and for 1 month after the last dose of the study drug. This includes methods like hormonal pills, patches, or devices placed inside the body, as well as surgical options like having the fallopian tubes blocked or having a partner who has had a vasectomy.
If a liver biopsy is needed, it must be safe and practical for the patient to have one. This involves taking a small sample of liver tissue to check for disease.
Must be between 18 and 75 years old at the first screening visit.
Must have a diagnosis of Primary Biliary Cholangitis (PBC), shown by at least two of the following: a history of high ALP levels for at least 6 months, positive tests for specific antibodies, or a liver biopsy showing PBC.
ALP levels must be at least 1.67 times the upper limit of normal.
Total bilirubin levels must be no more than 2 times the upper limit of normal.
Must have at least 4 recorded values for the PBC Worst Itch Numeric Rating Scale during each of the 7-day intervals in the 14 days before starting the study, totaling at least 8 values in the last 14 days.
Must have been taking UDCA for at least 12 months with a stable dose for at least 3 months before starting the study, or unable to tolerate UDCA for at least 3 months before starting the study.
If taking colchicine, the dose must be stable for at least 3 months before starting the study.
If taking medications for itching, such as cholestyramine, rifampin, naltrexone, or sertraline, the dose must be stable for at least 3 months before starting the study.

Who Cannot Join the Study?

Patients with other serious liver diseases besides Primary Biliary Cholangitis cannot participate. Primary Biliary Cholangitis is a condition where the bile ducts in the liver are slowly destroyed.
Individuals who have had a liver transplant are not eligible.
Patients with severe heart problems are excluded.
People with uncontrolled diabetes cannot take part. Uncontrolled diabetes means that blood sugar levels are not well managed.
Participants who have a history of cancer within the last 5 years, except for some skin cancers, are not allowed.
Women who are pregnant or breastfeeding cannot join the study.
Individuals who are currently participating in another clinical trial are not eligible.
Patients with known allergies to the study medication or similar drugs are excluded.
People with severe kidney problems cannot participate.
Individuals with certain infections, like hepatitis or HIV, are not eligible.
Patients who have a history of alcohol or drug abuse in the past year are excluded.
Anyone who cannot follow the study procedures or take the study medication as required is not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
CHU Grenoble Alpes	La Tronche	France
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Complexo Hospitalario Universitario De Pontevedra	Pontevedra	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Eugastro GmbH	Leipzig	Germany
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hopital Beaujon	Clichy	France
Cydnoj Hgfkmhykkdr Uypimixgbcass Raqla	Reims	France
Hxzpzpsr Uehkbbuzknlle Mehsrhx Dg Vqridxdzia	Santander	Spain
Gofdkf Uxlxqqvtor Fawxzrblw	Frankfurt	Germany
Hcxcgyzz Vqgs darozpss	Barcelona	Spain
Myt Gdgkyc Bzgmcu	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.09.2020
France	Not recruiting	01.09.2020
Germany	Not recruiting	01.09.2020
Italy	Not recruiting	01.09.2020
Spain	Not recruiting	01.09.2020

Trial locations

Investigated drugs:

Elafibranor

Elafibranor is a medication being studied for its potential to help patients with a liver condition called Primary Biliary Cholangitis. This condition affects the bile ducts in the liver. The trial is looking at how well Elafibranor works in patients who have not responded well to or cannot tolerate another treatment called Ursodeoxycholic Acid. The study aims to see if Elafibranor can improve liver function over a period of 52 weeks.

Primary Biliary Cholangitis – This is a chronic liver disease where the bile ducts in the liver become damaged and inflamed. Over time, this damage can lead to scarring of the liver tissue, known as cirrhosis. The disease progresses slowly, often over many years, and can cause symptoms such as fatigue, itching, and jaundice. As the bile ducts are destroyed, bile builds up in the liver, which can further damage liver cells. The exact cause of the disease is not well understood, but it is believed to involve an autoimmune response. It primarily affects middle-aged women and is considered a rare disease.

Trial ID:

2024-512232-30-00

Protocol code:

GFT505B-319-1

NCT ID:

NCT04526665

Trial Phase:

Therapeutic use (Phase IV)

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Study on Elafibranor for Patients with Primary Biliary Cholangitis Not Responding to Ursodeoxycholic Acid

What is this study about?

Who Can Join the Study?

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