Phase
Condition
Gall Bladder Disorders
Primary Biliary Cholangitis
Liver Disease
Treatment
Placebo
Elafibranor
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Male or female participants age ≥18 years of age.
Participants with a historical diagnosis of PBC as demonstrated by the presence of ≥2 of the following three historical diagnostic criteria:
i. History of elevated ALP levels for ≥6 months prior to the first screening visit (SV1).
ii. Positive Antimitochondrial antibody (AMA) titres (≥1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay) or positive PBC-specific antinuclear antibodies.
iii. Liver biopsy consistent with PBC.
ALP >1 × ULN and <1.67 × ULN.
Participants taking UDCA should have been on this medication for at least 6 months and at a stable dose for ≥3 months. Participants who are intolerant to UDCA should have taken the last dose of UDCA ≥3 months prior.
Participants taking medications for management of pruritus must be on a stable dose for ≥3 months.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- (a) Male participants must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception. The participant must agree to use contraception during the whole period of the study and for 30 days after the last dose of study intervention.
- Capable of giving signed informed consent
Exclusion Criteria
History or presence of other concomitant liver diseases.
Participants with known cirrhosis who have a Child-Pugh B or C score. Participants with cirrhosis with Child-Pugh A score are allowed.
History of liver transplantation.
History or presence of clinically significant hepatic decompensation.
Known history of human immunodeficiency virus (HIV) infection.
Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
Evidence of any other unstable or untreated clinically significant conditions that are not well controlled.
Medical condition with a life expectancy <2 years.
Known malignancy or history of malignancy within the last 2 years, except for successfully treated localised basal cell carcinoma or squamous cell carcinoma of the skin; or in-situ carcinoma of the uterine cervix.
History of hepatocellular carcinoma.
Alpha-foetoprotein (AFP) >20 ng/mL with 4-phase liver computed tomography (CT) or magnetic resonance imaging (MRI) scans suggesting presence of liver cancer.
Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below:
- i. Systemic (oral or parenteral) use within 3 months prior to SV1 of: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, or long-term systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs (including α-methyl-dopa, valproic acid, isoniazid or nitrofurantoin)
Participants with previous exposure to elafibranor.
Participants who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer.
Total bilirubin (TB) >2 × ULN. Participants with Gilbert's syndrome are eligible with a TB above 2 × ULN if direct bilirubin is <30% of TB.
Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5 × ULN.
Creatine phosphokinase (CPK) >2 × ULN.
Platelet count <75,000/µL.
International normalised ratio >1.3 in the absence of anticoagulant therapy.
Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2.
Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury).
Other exclusions
For female participants: known pregnancy, or has a positive serum pregnancy test, or is breastfeeding.
Regular alcohol intake in excess of the recommended limit of 2 standard drinks per day for men or 1 standard drink per day for women.
History of alcohol abuse, or other substance abuse within 1 year prior.
Known hypersensitivity to the investigational product or to any of the excipients of elafibranor.
Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
Any other condition that, in the opinion of the investigator, would interfere with study participation or completion, or would put the participant at risk, including a potential participant assessed as being at high risk of noncompliance with the study.
Study Design
Connect with a study center
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové,
CzechiaActive - Recruiting
Krajska Nemocnice Liberec
Liberec,
CzechiaSite Not Available
Artroscan
Ostrava,
CzechiaActive - Recruiting
Research Site s.r.o.
Plzen,
CzechiaActive - Recruiting
Institute for Clinical and Experimental Medicine - IKEM
Prague,
CzechiaActive - Recruiting
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille,
FranceActive - Recruiting
Cic Inserm 0802 - CHU Poitiers
Poitiers,
FranceActive - Recruiting
Clinique Pasteur
Toulouse,
FranceActive - Recruiting
Hopital Paul-Brousse - APHP
Villejuif,
FranceSite Not Available
Charite Universitatsmedizin Berlin
Berlin,
GermanySite Not Available
DRK Kliniken Berlin Mitte
Berlin,
GermanyActive - Recruiting
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
Frankfurt,
GermanyActive - Recruiting
Universitatsklinikum Heidelberg
Heidelberg,
GermanyActive - Recruiting
Gastroenterologsiche Studiengesellschaft Herne
Hemer,
GermanyActive - Recruiting
Universitaet Des Saarlandes
Homberg,
GermanyActive - Recruiting
Liver Study Centre Kiel
Kiel,
GermanySite Not Available
EUGASTRO GmbH
Leipzig,
GermanyActive - Recruiting
Universitaetsklinikum Muenster
Münster,
GermanyActive - Recruiting
Azienda Ospedaliera Universitaria Careggi Di Firenze
Firenze,
ItalyActive - Recruiting
Ospedale Policlinico San Martino - IRCCS
Genova,
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Modena
Modena,
ItalySite Not Available
Azienda Ospedaliero Universitaria Federico II di Napoli
Naples,
ItalyActive - Recruiting
Pusan National University Hospital (PNUH)
Naples,
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo,
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa,
ItalyActive - Recruiting
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
Rozzano,
ItalyActive - Recruiting
Korea University Ansan Hospital
Ansan si,
Korea, Republic ofActive - Recruiting
Keimyung University Dongsan Hospital
Daegu,
Korea, Republic ofActive - Recruiting
Kyungpook National University Hospital (KNUH)
Daegu,
Korea, Republic ofActive - Recruiting
The Catholic University of Korea Daejeon St.Mary's Hospital
Daejeon,
Korea, Republic ofActive - Recruiting
Pusan National University Hospital (PNUH)
Pusan,
Korea, Republic ofSite Not Available
CHA Bundang Medical Center, CHA University
Seongnam-si,
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital (SNUBH)
Seongnam-si,
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul,
Korea, Republic ofActive - Recruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul,
Korea, Republic ofActive - Recruiting
NZOZ Twoje Zdrowie EL Sp. z o.o.
Elbląg,
PolandSite Not Available
Krakowskie Centrum Medyczne Sp.z.o.o - FutureMeds
Kraków,
PolandActive - Recruiting
FutureMeds Warszawa Centrum
Warsaw,
PolandActive - Recruiting
CAROL DAVILA EMERGENCY UNIVERSITARY MILITARY HOSPITAL, Centrul Pentru Studiul Metabolismului, Research Metabolism Center
Bucuresti,
RomaniaActive - Recruiting
Spital Clinic Dr I Cantacuzino
Bucuresti,
RomaniaActive - Recruiting
Cluj County Clinical Emergency Hospital
Cluj-Napoca,
RomaniaActive - Recruiting
Gastromedica Srl
Iaşi,
RomaniaActive - Recruiting
Hospital Clinic i Provincial de Barcelona
Barcelona,
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron
Barcelona,
SpainActive - Recruiting
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid,
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid,
SpainActive - Recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda,
SpainActive - Recruiting
Hospital Universitario Virgen de la Victoria
Málaga,
SpainActive - Recruiting
Hospital De Montecelo
Pontevedra,
SpainSite Not Available
Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
Sabadell,
SpainActive - Recruiting
Hospital Universitario Marques De Valdecilla
Santander,
SpainSite Not Available
Hospital Universitario Rio Hortega
Valladolid,
SpainSite Not Available
Hospital Universitario Miguel Servet
Zaragoza,
SpainActive - Recruiting
Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
Aberdeen,
United KingdomActive - Recruiting
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
Bradford,
United KingdomActive - Recruiting
Frimley Park Hospital - Frimley Health NHS Foundation Trust
Frimley,
United KingdomActive - Recruiting
Queen Elizabeth University Hospital - Greater Glasgow Health Board
Glasgow,
United KingdomActive - Recruiting
Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust
Hull,
United KingdomActive - Recruiting
Ambrose King Centre-Royal London Hospital-Barts Health NHS Trust
London,
United KingdomActive - Recruiting
King's College Hospital
London,
United KingdomSite Not Available
The Royal Free Hospital - Royal Free London NHS Foundation Trust
London,
United KingdomSite Not Available
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle Upon Tyne,
United KingdomSite Not Available
Queen's Medical Centre - Nottingham University Hospitals NHS Trust
Nottingham,
United KingdomSite Not Available
John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford,
United KingdomSite Not Available
Kindred Medical Institute for Clinical Trials
Corona, California 92879
United StatesSite Not Available
Southern California Research Center
Coronado, California 92118
United StatesActive - Recruiting
Topgraphy Health, Inc.
Los Angeles, California 90005
United StatesActive - Recruiting
University of California Los Angeles
Los Angeles, California 90095
United StatesSite Not Available
University of California, Davis
Sacramento, California 95616
United StatesActive - Recruiting
Stanford University Medical Center
Stanford, California 94305
United StatesActive - Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado 80135
United StatesActive - Recruiting
Rocky Mountain Gastroenterology
Littleton, Colorado 80120
United StatesActive - Recruiting
International Center for Research
Tampa, Florida 33614
United StatesActive - Recruiting
Delta Research Partners, LLC
West Monroe, Louisiana 71291
United StatesActive - Recruiting
University of Michigan Health System
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Huron Gastroenterology Associates - Center for Digestive Care
Ypsilanti, Michigan 48197
United StatesActive - Recruiting
South Denver Gastroenterology,P.C.
Englewood, New Jersey 80113
United StatesActive - Recruiting
Southwest Gastroenterology Associates, PC (SWGA)
Albuquerque, New Mexico 87109
United StatesActive - Recruiting
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York 11030
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina 28277
United StatesActive - Recruiting
Coastal Research Institute
Fayetteville, North Carolina 28304
United StatesActive - Recruiting
Gastroenterology Center of the Midsouth
Cordova, Tennessee 38018
United StatesActive - Recruiting
Methodist Transplant Physicians
Dallas, Texas 75203
United StatesActive - Recruiting
Liver Associates of Texas, P.A.
Houston, Texas 77030
United StatesActive - Recruiting
Gastro health & Nutrition
Katy, Texas 77494
United StatesSite Not Available
American Research Corporation
San Antonio, Texas 78215
United StatesActive - Recruiting
American Research Corporation at The Texas Liver Institute
San Antonio, Texas 78215
United StatesActive - Recruiting
University of Virginia Medical Center
Charlottesville, Virginia 22903
United StatesSite Not Available
Bon Secours Richmond Community Hospital d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia 23226
United StatesActive - Recruiting
Velocity Liver Institute NW
Seattle, Washington 98105
United StatesActive - Recruiting
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