Study of Elafibranor in Adults with Primary Biliary Cholangitis Who Don’t Respond Well to or Cannot Tolerate Ursodeoxycholic Acid Treatment

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What is this study about?

This study focuses on Primary Biliary Cholangitis (PBC), a long-term liver disease that causes the bile ducts in the liver to become damaged. The research evaluates a medication called elafibranor in patients who have not responded well to or cannot tolerate standard treatment with ursodeoxycholic acid. The purpose is to determine if elafibranor can help normalize liver enzyme levels in adults with this condition.

The study will test film-coated tablets containing 80 mg of elafibranor compared to placebo in adult patients. The treatment will be given as a daily oral dose for 52 weeks. During this time, researchers will monitor changes in liver function, particularly focusing on levels of alkaline phosphatase, an enzyme that indicates liver health.

Throughout the study, participants will have their symptoms assessed, including itching severity and quality of life. The research will also track any changes in liver function tests and monitor the overall safety of the treatment. The study uses various questionnaires to measure how participants feel and function during their daily activities while receiving the treatment.

1 Initial medication assignment

You will be randomly assigned to receive either elafibranor (80 mg film-coated tablet) or a matching placebo tablet

The medication needs to be taken orally once daily

The study will last for 52 weeks (1 year)

2 Regular check-ups – Week 4

Your first follow-up visit will occur 4 weeks after starting treatment

Medical staff will measure your alkaline phosphatase (ALP) levels

You will complete questionnaires about your symptoms, including any itching you may experience

3 Follow-up visits – Weeks 12 and 24

Additional check-ups will take place at weeks 12 and 24

Your blood will be tested to monitor liver function

Your overall health status will be evaluated

At week 24, you will complete quality of life assessments

4 Continued monitoring – Weeks 36 and 52

Further evaluations will occur at weeks 36 and 52

Final blood tests will be performed to measure ALP and bilirubin levels

The study will conclude at week 52 with final health assessments

5 Safety monitoring

Throughout the study, you will be monitored for any side effects

Regular physical examinations will be conducted

Your vital signs and heart activity (ECG) will be checked

Laboratory tests will continue to monitor your health status

Who Can Join the Study?

  • Must be at least 18 years old
  • Must have a confirmed diagnosis of Primary Biliary Cholangitis (PBC) with at least 2 of these conditions:
    • History of elevated alkaline phosphatase (ALP) levels for 6 months or more
    • Positive antimitochondrial antibody test
    • Liver biopsy showing PBC
  • Must have ALP levels above normal but not more than 1.67 times the upper normal limit
  • If taking UDCA (a medication for PBC):
    • Must have been taking it for at least 12 months
    • Must be on a stable dose for at least 6 months
    • If unable to take UDCA, must have stopped it at least 3 months ago
  • If taking medications for itching, must be on a stable dose for at least 3 months
  • Must follow specific contraception requirements:
    • Men must agree to use condoms and not donate sperm during the study and for 30 days after
    • Women who can become pregnant must use effective contraception methods and have a negative pregnancy test
    • Women must not be pregnant or breastfeeding
  • Must be able to understand and sign the informed consent form

Who Cannot Join the Study?

  • Age below 18 years old
  • Pregnant or breastfeeding women
  • History of liver transplantation
  • Current diagnosis of cirrhosis (severe scarring of the liver) with complications
  • Presence of other liver diseases besides Primary Biliary Cholangitis (PBC)
  • Current or recent use of medications that could interact with the study drug
  • Severe kidney problems (as measured by blood tests)
  • Uncontrolled high blood pressure
  • History of heart problems in the past 6 months
  • Active cancer or cancer treatment within the past 5 years
  • History of alcohol or drug abuse within the past 2 years
  • Participation in another clinical trial within the past 30 days
  • Known allergies to the study medication or its components
  • Abnormal blood test results that could indicate other health problems
  • Mental health conditions that could interfere with study participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland
IRCCS Humanitas Research Hospital Rozzano Italy
Clinique Pasteur Toulouse France
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Lille Lille France
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania
Futuremeds Sp. z o.o. Wroclaw Poland

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Eugastro GmbH Leipzig Germany
Gastromedica S.R.L. Iasi Romania
Hightech Medical Services S.R.L. Bucharest Romania
RESEARCH SITE s.r.o Plzen Czechia
Hospital Clinic De Barcelona Barcelona Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Hospital Paul Brousse Villejuif France
Krajska nemocnice Liberec a.s. Liberec Czechia
Hospital Universitario Virgen De La Victoria Malaga Spain
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Gastroenterologische Gemeinschaftspraxis Herne Herne Germany
Ilfhthpbl Fst Cifopvsx Acm Ewgjbybxjpps Msdvefdz Prague Czechia
Pppy Tcxvw Hduuqodv Uvaqdsscahbh Sabadell Spain
Syhonjyb Caougc &litnklmrc Ig Cddishozyfcerilebn Bucharest Romania
Ugnbapjwtawtgcrojrmpv Myhpuxff Amy Munster Germany
Fbedpugdm Pqwf Lj Iiqzyyxpiwyho Batfpwhcf Dxd Hqzrkacl Uxepltuoyztvu Lm Pcy Madrid Spain
Hiyumwti Vxdh dqcxehlb Barcelona Spain
Atfmcvwht srsgwa Trebovice Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
21.10.2024
France France
Not recruiting
21.10.2024
Germany Germany
Not recruiting
21.10.2024
Italy Italy
Not recruiting
21.10.2024
Poland Poland
Not recruiting
21.10.2024
Romania Romania
Not recruiting
21.10.2024
Spain Spain
Not recruiting
21.10.2024

Trial locations

Investigated drugs:

Elafibranor is a medication being studied for treating Primary Biliary Cholangitis (PBC), a liver condition. It works by targeting certain receptors in the liver that help reduce inflammation and improve liver function. This medication is taken orally and is being tested in patients who haven’t responded well to standard treatments or couldn’t tolerate them.

Ursodeoxycholic Acid is a standard medication used to treat Primary Biliary Cholangitis. It’s a naturally occurring bile acid that helps improve liver function by reducing the buildup of harmful bile acids. This medication is mentioned as the previous treatment that patients in the study either didn’t respond well to or couldn’t tolerate.

Primary Biliary Cholangitis (PBC) – A chronic liver disease that primarily affects women and slowly damages the bile ducts in the liver. The condition causes inflammation and scarring of the small bile ducts, which leads to bile buildup in the liver. Over time, this progressive disease causes the bile ducts to be destroyed, allowing harmful substances to build up in the liver. The disease typically develops slowly over many years, gradually affecting the liver’s ability to function properly. PBC often begins with inflammation that may cause fatigue and itching, while the bile ducts become increasingly damaged.

Trial ID:
2024-510695-20-00
Protocol code:
CLIN-60190-463
NCT ID:
NCT06383403
Trial Phase:
Therapeutic confirmatory (Phase III)

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