Actively Recruiting
A Phase III Study Evaluating Elafibranor 80 mg for Long-Term Outcomes in Adults With Primary Biliary Cholangitis (PBC)
Led by Ipsen · Updated on 2026-06-01
276
Participants Needed
183
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of elafibranor in adults with Primary Biliary Cholangitis (PBC) who also have cirrhosis, a serious liver condition involving scarring. PBC is a slowly progressing disease that damages bile ducts, causing bile acids to build up and harm the liver further. This study aims to see if elafibranor can better prevent worsening of the disease, including the need for liver transplant or death, compared to a placebo. The safety of long-term use and effects on symptoms like itching and tiredness will also be assessed. Participants will be randomly assigned to take either one 80 mg tablet of elafibranor or a matching placebo tablet once daily, taken orally with or without food, at about the same time each morning. The treatment period can last up to 3.5 years in a double-blind setting, meaning neither participants nor researchers know who receives the drug or placebo. This design allows a direct comparison of elafibranor's impact on disease progression and safety over a long term. Throughout the study, participants will undergo regular assessments including blood tests, physical exams, vital signs, ECGs, and liver imaging to monitor liver function and stiffness. Researchers will track a range of outcomes such as survival without clinical events, changes in liver and blood markers, symptom severity, and quality of life measures. Safety monitoring will continue until 4 weeks after the last dose. Each participant may be involved for up to 3.5 years from baseline to final evaluation.
CONDITIONS
Brief Title
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older at informed consent
- Definite or probable diagnosis of Primary Biliary Cholangitis (PBC)
- Presence of cirrhosis at screening visit
- Classified as Child Pugh A or Child Pugh B
- Use of contraception consistent with local regulations for study participation
- Ability to provide signed informed consent and comply with study requirements
You will not qualify if you...
- Presence of other liver diseases such as Primary Sclerosing Cholangitis, Autoimmune Hepatitis, Hepatitis B or C, Alcohol-associated liver disease, Nonalcoholic steatohepatitis, or alpha-1 antitrypsin deficiency
- History or presence of significant liver complications including previous liver transplant, current transplant listing, high MELD score, uncontrolled ascites, variceal bleeding, hepatic encephalopathy grade 2 or higher, spontaneous bacterial peritonitis, or hepatorenal syndrome
- Hospitalization for liver-related complication within 12 weeks prior to screening
- Known HIV infection
- Medical conditions causing non-hepatic alkaline phosphatase elevation
- Unstable or untreated significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric diseases
- Non-hepatic conditions reducing life expectancy to less than 2 years, including cancers
- History of hepatocellular carcinoma or positive imaging suggesting it
- Malignancy within the last 5 years except certain treated skin or in situ cancers
- Recent use of prohibited medications including fibrates, certain immunosuppressants, corticosteroids, and potentially hepatotoxic drugs
- Participation in another investigational drug or device study within 30 days or 5 half-lives, with some exceptions for prior PBC therapies
- Electrocardiogram findings with prolonged QTc interval beyond set limits
- Laboratory abnormalities such as bilirubin greater than 5 times upper limit, ALT or AST over 5 times upper limit, elevated creatinine phosphokinase, low platelet count, elevated INR without anticoagulation, reduced kidney function, or significant renal disease
- Current pregnancy, positive pregnancy test, or breastfeeding
- Unwillingness or inability to abstain from alcohol during the study
- History of alcohol or substance abuse within 1 year prior to screening
- Known hypersensitivity to elafibranor or its excipients
- Mental instability or inability to provide valid informed consent or comply with study
- Any condition that may interfere with study participation or increase risk
- Alkaline phosphatase greater than 10 times upper limit
- Albumin less than 2.8 g/dL due to liver impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 42 months (3.5 years)
Participants take one tablet of elafibranor 80 mg or matching placebo once daily for up to 42 months (3.5 years).
Visits approximately every 6 to 12 months during treatment
Duration - 4 weeks
Participants are monitored for safety and clinical outcomes for 4 weeks after the last dose of study intervention.
1 follow-up visit (in-person)
Trial Site Locations
Total: 183 locations
1
Arizona Liver Health
Tucson, Arizona, United States, 85641
Actively Recruiting
2
Arkansas Diagnostic Center, PA
Little Rock, Arkansas, United States, 55130
Terminated
3
Southern California Research Center
Coronado, California, United States, 92118
Actively Recruiting
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Active, Not Recruiting
5
GastroIntestinal BioSciences
Los Angeles, California, United States, 90067
Actively Recruiting
6
University of California Los Angeles
Los Angeles, California, United States, 90404
Withdrawn
7
University of California Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
8
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
9
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80829
Actively Recruiting
10
South Denver Gastroenterology, P.C.
Englewood, Colorado, United States, 80113
Actively Recruiting
11
Rocky Mountain Gastroenterology
Littleton, Colorado, United States, 80120
Actively Recruiting
12
University Of Miami School Of Medicine, Center For Liver Diseases
Miami, Florida, United States, 33136
Actively Recruiting
13
Bolanos Clinical Research
Pembroke Pines, Florida, United States, 12105
Actively Recruiting
14
International Center for Research
Tampa, Florida, United States, 33614
Actively Recruiting
15
University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
16
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71103
Actively Recruiting
17
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
18
Huron Gastroenterology Associates - Center for Digestive Care
Ypsilanti, Michigan, United States, 48197
Active, Not Recruiting
19
Southwest Gastroenterology Associates, PC (SWGA)
Albuquerque, New Mexico, United States, 87109
Active, Not Recruiting
20
NYU Langone Gastroenterology and Hepatology Associates
New York, New York, United States, 10016
Actively Recruiting
21
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
22
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
23
Gastroenterology Center of the Midsouth
Cordova, Tennessee, United States, 38138
Actively Recruiting
24
Texas Clinical Research Institute
Arlington, Texas, United States, 22201
Actively Recruiting
25
American Research Corporation
Austin, Texas, United States, 78757
Actively Recruiting
26
Rush University Medical Center - University Cardiovascular Surgeons
Dallas, Texas, United States, 60612
Withdrawn
27
Liver Center of Texas
Dallas, Texas, United States, 75203
Active, Not Recruiting
28
Methodist Transplant Physicians
Dallas, Texas, United States, 75203
Actively Recruiting
29
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
30
Baylor Scott & White All Saints Medical Center - Forth Worth
Fort Worth, Texas, United States, 76104
Withdrawn
31
Liver Associates of Texas
Houston, Texas, United States, 77030
Actively Recruiting
32
Houston Methodist Cancer Center
Houston, Texas, United States, 77584
Actively Recruiting
33
Gastro health & Nutrition
Katy, Texas, United States, 77904
Withdrawn
34
American Research Corporation at The Texas Liver Institute
San Antonio, Texas, United States, 78015
Actively Recruiting
35
Impact Research Tx
Waco, Texas, United States, 76710
Withdrawn
36
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
37
Bon Secours St. Mary's Hospital of Richmond, Inc
Richmond, Virginia, United States, 23226
Actively Recruiting
38
Virginia Commonwealth University Medical Center - West Hospital
Richmond, Virginia, United States, 23298
Not Yet Recruiting
39
Medstar Georgetown Transplant Institute University Hospital (MGUH)
Columbia, Washington, United States, 20007
Withdrawn
40
Velocity Clinical Research at Liver Institute Northwest
Seattle, Washington, United States, 98105
Actively Recruiting
41
DIM Centro Medico
Buenos Aires, Argentina
Actively Recruiting
42
Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L
Buenos Aires, Argentina
Actively Recruiting
43
Hospital Britanico de Buenos Aires
Buenos Aires, Argentina
Actively Recruiting
44
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Actively Recruiting
45
Centro Medico Colon
Córdoba, Argentina
Actively Recruiting
46
Hospital Espanol de Mendoza
Mendoza, Argentina
Withdrawn
47
Hospital Universitario Austral
Pilar, Argentina
Actively Recruiting
48
Hospital El Cruce
San Juan Bautista, Argentina
Actively Recruiting
49
Sunshine Coast University Hospital
Birtinya, Australia
Actively Recruiting
50
Footscray Hospital, Western Health
Footscray, Australia
Actively Recruiting
51
Nepean Clinical School
Kingswood, Australia
Active, Not Recruiting
52
Monash University - Monash Health -Monash Medical Centre
Melbourne, Australia
Withdrawn
53
St George Hospital
Sydney, Australia
Withdrawn
54
Westmead Hospital
Westmead, Australia
Actively Recruiting
55
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Actively Recruiting
56
Ziekenhuis Oost-Limburg
Genk, Belgium
Actively Recruiting
57
Gent University Hospital
Ghent, Belgium
Actively Recruiting
58
Algemeen Ziekenhuis Delta
Roeselare, Belgium
Actively Recruiting
59
NUPEC Cardio
Belo Horizonte, Brazil
Actively Recruiting
60
Universidade Federal de Goias
Goiânia, Brazil
Actively Recruiting
61
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, Brazil
Actively Recruiting
62
Instituto D'Or de Pesquisa e Ensino - Hospital Aliança
Salvador, Brazil
Actively Recruiting
63
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, Brazil
Actively Recruiting
64
Hospital de Base - Centro Integrado de Pesquisa ( CIP )
São Paulo, Brazil
Actively Recruiting
65
Universidade Estadual Paulista Julio De Mesquita Filho (UNESP) Hospital das Clinicas Faculdade de Medicina de Botucatu (HCFMB)
São Paulo, Brazil
Actively Recruiting
66
Diagnostic-Consultative Center Aleksandrovska EOOD
Sofia, Bulgaria
Actively Recruiting
67
Tokuda Hospital, Dept. of Internal Medicine
Sofia, Bulgaria
Actively Recruiting
68
University Hospital City Clinic Cancer Center
Sofia, Bulgaria
Actively Recruiting
69
University of Alberta - Faculty of Medicine & Dentistry - The Centre of Excellence for Gastrointestinal Inflammation and Immunity Research (CEGIIR)
Edmonton, Canada
Actively Recruiting
70
University Health Network (UHN) - Toronto General Hospital (TGH) - Toronto General Research Institute (TGRI)
Toronto, Canada
Actively Recruiting
71
Universidad De Los Andes
Las Condes, Chile
Actively Recruiting
72
Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)
Santiago, Chile
Actively Recruiting
73
Enroll SpA
Santiago, Chile
Actively Recruiting
74
Hospital Clinico de la Pontificia Universidad Catolica de Chile
Santiago, Chile
Actively Recruiting
75
University of Chile Clinical Hospital (Hospital Clinico de la Universidad de Chile)
Santiago, Chile
Actively Recruiting
76
Centro Medico Cedid - Centro de Diagnostico Digestivo
Viña del Mar, Chile
Actively Recruiting
77
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, Czechia
Actively Recruiting
78
Krajska Nemocnice Liberec
Liberec, Czechia
Withdrawn
79
Artroscan
Ostrava, Czechia
Actively Recruiting
80
Research Site s.r.o.
Pilsen, Czechia
Actively Recruiting
81
Institute for Clinical and Experimental Medicine - IKEM
Prague, Czechia
Actively Recruiting
82
Bispebjerg Hospital
Copenhagen, Denmark
Actively Recruiting
83
Hospital Henri Mondor
Créteil, France, 94000
Actively Recruiting
84
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, France
Actively Recruiting
85
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
Lyon, France
Actively Recruiting
86
Hopital Saint Joseph - Marseille
Marseille, France
Withdrawn
87
CHU de Nice, Hopital de l'Archet
Nice, France
Actively Recruiting
88
Hopital Pitie-Salpetriere - APHP
Paris, France, 75013
Actively Recruiting
89
CHU Poitiers
Poitiers, France
Actively Recruiting
90
Clinique Pasteur
Toulouse, France
Actively Recruiting
91
Hopital Paul-Brousse - APHP
Villejuif, France
Actively Recruiting
92
Agios Savvas Regional Cancer Hospital
Athens, Greece
Actively Recruiting
93
General Hospital of Athens Laiko
Athens, Greece
Actively Recruiting
94
General Oncological Hospital of Kifisia Oi Agioi Anargyroi
Athens, Greece
Actively Recruiting
95
GeneIppokratio General Hospital of Thessaloniki
Thessaloniki, Greece
Actively Recruiting
96
Central Hospital of Northern Pest - Military Hospital
Budapest, Hungary
Actively Recruiting
97
Kenezy County Hospital
Debrecen, Hungary
Actively Recruiting
98
Szegedi Tudomanyegyetem AOK, I. sz Belgyogyaszati Klinika
Szeged, Hungary
Actively Recruiting
99
Institute of Gastroenterology and Liver Diseases - Soroka University Medical Center
Beersheba, Israel
Suspended
100
Rambam Health Care Campus (RHCC)
Haifa, Israel
Suspended
101
Hadassah University Hospital (HUH) - Ein-Kerem
Jerusalem, Israel
Suspended
102
Shaare Zedek Medical Center
Jerusalem, Israel
Suspended
103
Galilee Medical Center, ZIV Medical Center
Nahariya, Israel
Suspended
104
Galilee Medical Center
Nahariya, Israel
Suspended
105
Rabin Medical Center - Beilinson Hospital - Liver Institute
Petah Tikva, Israel
Suspended
106
Azienda Ospedaliero Universitaria Modena
Modena, Italy
Withdrawn
107
Ospedale San Gerardo
Monza, Italy
Actively Recruiting
108
Azienda Ospedaliero Universitaria Federico II di Napoli
Naples, Italy
Withdrawn
109
Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
Padova, Italy
Actively Recruiting
110
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Active, Not Recruiting
111
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, Italy
Withdrawn
112
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Withdrawn
113
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Actively Recruiting
114
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, Lithuania
Actively Recruiting
115
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Actively Recruiting
116
Hospital Sultanah Aminah
Johor Bahru, Malaysia
Actively Recruiting
117
Hospital Queen Elizabeth II
Kota Kinabalu, Malaysia
Actively Recruiting
118
University of Malaya Medical Centre
Kuala Lumpur, Malaysia
Actively Recruiting
119
Centro de Investigacion Clinica y Medicina Traslacional
Guadalajara, Mexico
Actively Recruiting
120
Centro de Investigacion Medico Biologica y Terapia Avanzada
Jalisco, Mexico
Actively Recruiting
121
Centro de Investigacion y Gastroenterologia SC
Mexico City, Mexico
Actively Recruiting
122
Hospital Angeles Valle Oriente
Monterrey, Mexico
Actively Recruiting
123
Medical Care & Research
Yucatán, Mexico
Actively Recruiting
124
Canterbury District Health Board
Christchurch, New Zealand
Actively Recruiting
125
Waikato Hospital
Hamilton, New Zealand
Actively Recruiting
126
NZOZ Twoje Zdrowie EL Sp. z o.o.
Elblag, Poland
Actively Recruiting
127
Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
Katowice, Poland
Actively Recruiting
128
Krakowskie Centrum Medyczne Sp.z.o.o - FutureMeds
Krakow, Poland
Actively Recruiting
129
Szpital Uniwersytecki w Krakowie
Krakow, Poland
Withdrawn
130
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ, Uniwersytecki Szpital Kliniczny im. Barlickiego w Lodzi
Lodz, Poland, 90-153
Actively Recruiting
131
Medrise Sp. z o.o.
Lublin, Poland
Actively Recruiting
132
Krakowskie Centrum Medyczne Sp.z.o.o. - FutureMeds
Małogoskie, Poland
Not Yet Recruiting
133
Centrum Medyczne Medyk Sp. z o.o. Sp. K.
Rzeszów, Poland
Actively Recruiting
134
Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poliklinika Doktora Bessera
Sosnowiec, Poland
Withdrawn
135
FutureMeds Warszawa Centrum
Warsaw, Poland
Actively Recruiting
136
FutureMeds sp. z o. o
Wroclaw, Poland
Actively Recruiting
137
Nzoz Centrum BadanKlinicznych
Wroclaw, Poland
Actively Recruiting
138
PlanetMed Sp. z o.o.
Wroclaw, Poland
Actively Recruiting
139
Hospital Dr. Nelio Mendonca
Funchal, Portugal, 9004-514
Actively Recruiting
140
Unidade Local de Saúde de Trás-os-Montes e Alto Douro, E. P. E
Vila Real, Portugal, 5000-508
Actively Recruiting
141
Centrul Pentru Studiul Metabolismului
Bucharest, Romania
Actively Recruiting
142
Sana S.R.L
Bucharest, Romania
Actively Recruiting
143
Spital Clinic Dr I Cantacuzino
Bucharest, Romania
Actively Recruiting
144
Cluj County Clinical Emergency Hospital
Cluj-Napoca, Romania
Actively Recruiting
145
Gastromedica Srl
Iași, Romania, 700111
Actively Recruiting
146
Gastroenterological Centre Thalion
Bratislava, Slovakia
Actively Recruiting
147
Univerzitna nemocnica L. Pasteura Kosice
Košice, Slovakia
Not Yet Recruiting
148
Fakultna nemocnica Nitra
Nitra, Slovakia
Actively Recruiting
149
Pusan National University Hospital (PNUH)
Busan, South Korea
Actively Recruiting
150
Keimyung University Dongsan Hospital
Daegu, South Korea
Actively Recruiting
151
The Catholic University of Korea Daejeon St.Mary's Hospital
Daejeon, South Korea
Active, Not Recruiting
152
Inje University Ilsan Paik Hospital
Goyang-si, South Korea
Actively Recruiting
153
Korea University Ansan Hospital
Gyeonggi-do, South Korea
Actively Recruiting
154
Inha University Hospital
Incheon, South Korea
Actively Recruiting
155
Kyungpook National University Hospital (KNUH)
Junggu, South Korea
Actively Recruiting
156
CHA Bundang Medical Center, CHA University
Seongnam-si, South Korea
Actively Recruiting
157
Chung-Ang University Hospital
Seoul, South Korea
Actively Recruiting
158
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Withdrawn
159
Hanyang University Seoul Hospital
Seoul, South Korea
Actively Recruiting
160
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
161
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
162
Seoul National University Bundang Hospital (SNUBH)
Seoul, South Korea
Actively Recruiting
163
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
164
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Withdrawn
165
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
166
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
167
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea
Actively Recruiting
168
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Actively Recruiting
169
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Actively Recruiting
170
Clinica Universidad Navarra-Sede Madrid
Madrid, Spain
Actively Recruiting
171
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, Spain
Active, Not Recruiting
172
Hospital Universitario La Paz
Madrid, Spain
Withdrawn
173
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, Spain
Actively Recruiting
174
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Actively Recruiting
175
Hospital De Montecelo
Pontevedra, Spain
Actively Recruiting
176
Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
Sabadell, Spain
Actively Recruiting
177
Hospital Universitario Virgen del Rocio
Seville, Spain
Actively Recruiting
178
Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
179
Hospital Universitario Rio Hortega
Valladolid, Spain
Active, Not Recruiting
180
Hospital Universitario Miguel Servet
Zaragoza, Spain
Actively Recruiting
181
Chiang Mai University
Chiang Mai, Thailand
Actively Recruiting
182
Prince of Songkla University (PSU) - Songklanagarind Hospital
Hat Yai, Thailand
Actively Recruiting
183
Srinagarind Hospital - Khon Kaen University
Khon Kaen, Thailand
Actively Recruiting
Research Team
I
Ipsen Clinical Study Enquiries
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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