Actively Recruiting
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
Led by Ipsen · Updated on 2026-04-30
276
Participants Needed
180
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant. The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death). This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.
CONDITIONS
Official 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 18 years of age or older at consent
- Confirmed definite or probable diagnosis of Primary Biliary Cholangitis (PBC)
- Presence of cirrhosis classified as Child Pugh A or Child Pugh B at screening visit
- Use of contraception consistent with local regulations for clinical study participation
- Ability to provide signed informed consent and comply with study requirements
You will not qualify if you...
- History or presence of other liver diseases including primary sclerosing cholangitis, autoimmune hepatitis, hepatitis B or C infection, alcohol-associated liver disease, nonalcoholic steatohepatitis, or other chronic liver diseases
- History of clinically significant liver decompensation or complications like uncontrolled ascites, variceal bleeding, hepatic encephalopathy Grade 2 or higher, or hepatorenal syndrome
- History of liver transplantation or current placement on liver transplant list
- Known HIV infection
- Medical conditions causing non-hepatic increases in alkaline phosphatase
- Unstable or untreated significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric diseases
- Non-hepatic conditions limiting life expectancy to less than 2 years including cancers
- History or evidence of hepatocellular carcinoma
- Use of prohibited medications within specified timeframes prior to screening
- Prolonged QT interval on ECG exceeding defined thresholds
- Total bilirubin greater than 5 times the upper limit of normal
- Elevated liver enzymes ALT or AST greater than 5 times the upper limit of normal at screening
- Elevated creatinine phosphokinase greater than twice the upper limit of normal
- Platelet count below 50,000/bcL
- International normalized ratio above 1.8 without anticoagulant therapy
- Estimated glomerular filtration rate below 45 mL/min/1.73m2
- Significant renal disease including nephritic syndrome or chronic kidney disease
- Current pregnancy, positive pregnancy test, or breastfeeding for female participants
- Unwillingness or inability to abstain from alcohol during the study
- History of alcohol or substance abuse within one year prior to screening
- Known hypersensitivity to elafibranor or its components
- Mental instability or inability to comply with study requirements
- Alkaline phosphatase greater than or equal to 10 times the upper limit of normal
- Albumin less than 2.8 g/dL due to impaired liver function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 180 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
Actively 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
Actively 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
Actively Recruiting
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
Not Yet 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
Actively Recruiting
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
Actively Recruiting
52
Monash University - Monash Health -Monash Medical Centre
Melbourne, Australia
Actively Recruiting
53
St George Hospital
Sydney, Australia
Actively Recruiting
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
Not Yet Recruiting
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
Actively Recruiting
107
Ospedale San Gerardo
Monza, Italy
Actively Recruiting
108
Azienda Ospedaliero Universitaria Federico II di Napoli
Naples, Italy
Actively Recruiting
109
Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
Padova, Italy
Actively Recruiting
110
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Actively Recruiting
111
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, Italy
Withdrawn
112
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Not Yet Recruiting
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
Not Yet 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
Medrise Sp. z o.o.
Lublin, Poland
Actively Recruiting
131
Krakowskie Centrum Medyczne Sp.z.o.o. - FutureMeds
Małogoskie, Poland
Not Yet Recruiting
132
Centrum Medyczne Medyk Sp. z o.o. Sp. K.
Rzeszów, Poland
Actively Recruiting
133
Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poliklinika Doktora Bessera
Sosnowiec, Poland
Withdrawn
134
FutureMeds Warszawa Centrum
Warsaw, Poland
Actively Recruiting
135
FutureMeds sp. z o. o
Wroclaw, Poland
Actively Recruiting
136
Nzoz Centrum BadanKlinicznych
Wroclaw, Poland
Actively Recruiting
137
PlanetMed Sp. z o.o.
Wroclaw, Poland
Actively Recruiting
138
Hospital Dr. Nelio Mendonca
Funchal, Portugal, 9004-514
Actively Recruiting
139
Unidade Local de Saúde de Trás-os-Montes e Alto Douro, E. P. E
Vila Real, Portugal, 5000-508
Actively Recruiting
140
Centrul Pentru Studiul Metabolismului
Bucharest, Romania
Actively Recruiting
141
Sana S.R.L
Bucharest, Romania
Actively Recruiting
142
Spital Clinic Dr I Cantacuzino
Bucharest, Romania
Actively Recruiting
143
Cluj County Clinical Emergency Hospital
Cluj-Napoca, Romania
Actively Recruiting
144
Gastromedica Srl
Iași, Romania, 700111
Actively Recruiting
145
Gastroenterological Centre Thalion
Bratislava, Slovakia
Actively Recruiting
146
Univerzitna nemocnica L. Pasteura Kosice
Košice, Slovakia
Not Yet Recruiting
147
Fakultna nemocnica Nitra
Nitra, Slovakia
Not Yet Recruiting
148
Pusan National University Hospital (PNUH)
Busan, South Korea
Actively Recruiting
149
Keimyung University Dongsan Hospital
Daegu, South Korea
Actively Recruiting
150
The Catholic University of Korea Daejeon St.Mary's Hospital
Daejeon, South Korea
Actively Recruiting
151
Inje University Ilsan Paik Hospital
Goyang-si, South Korea
Actively Recruiting
152
Korea University Ansan Hospital
Gyeonggi-do, South Korea
Actively Recruiting
153
Inha University Hospital
Incheon, South Korea
Actively Recruiting
154
Kyungpook National University Hospital (KNUH)
Junggu, South Korea
Actively Recruiting
155
CHA Bundang Medical Center, CHA University
Seongnam-si, South Korea
Actively Recruiting
156
Chung-Ang University Hospital
Seoul, South Korea
Actively Recruiting
157
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Withdrawn
158
Hanyang University Seoul Hospital
Seoul, South Korea
Actively Recruiting
159
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
160
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
161
Seoul National University Bundang Hospital (SNUBH)
Seoul, South Korea
Actively Recruiting
162
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
163
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
164
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
165
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
166
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea
Actively Recruiting
167
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Actively Recruiting
168
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Actively Recruiting
169
Clinica Universidad Navarra-Sede Madrid
Madrid, Spain
Actively Recruiting
170
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, Spain
Actively Recruiting
171
Hospital Universitario La Paz
Madrid, Spain
Not Yet Recruiting
172
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, Spain
Actively Recruiting
173
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Actively Recruiting
174
Hospital De Montecelo
Pontevedra, Spain
Withdrawn
175
Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
Sabadell, Spain
Actively Recruiting
176
Hospital Universitario Virgen del Rocio
Seville, Spain
Actively Recruiting
177
Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
178
Hospital Universitario Rio Hortega
Valladolid, Spain
Active, Not Recruiting
179
Hospital Universitario Miguel Servet
Zaragoza, Spain
Actively Recruiting
180
Chiang Mai University
Chiang Mai, Thailand
Actively Recruiting
Research Team
I
Ipsen Clinical Study Enquiries
CONTACT
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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