Actively Recruiting
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Led by Gilead Sciences · Updated on 2026-04-30
318
Participants Needed
196
Research Sites
360 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
CONDITIONS
Official Title
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Confirmed prior diagnosis of Primary Biliary Cholangitis (PBC)
- Evidence of cirrhosis
- Child-Pugh score A or B
- Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose
- Male participants sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
- Ability to follow study drug instructions and complete the study schedule of assessments
You will not qualify if you...
- Prior exposure to seladelpar
- Any medical condition other than PBC that would prevent full study participation as judged by the investigator
- History of liver transplantation or currently listed for liver transplant
- Decompensated cirrhosis
- Evidence of portal vein thrombosis on imaging
- Hospitalization for liver-related complications within 12 weeks before screening
- Laboratory values at screening outside specified limits including ALP <1.5x or ≥10x ULN, ALT or AST ≥5x ULN, total bilirubin ≤0.6x or ≥5x ULN, platelet count ≤50,000/µL, albumin ≤2.8 g/dL, eGFR <45 mL/min/1.73 m², MELD score >12, serum alpha-fetoprotein >20 ng/mL, INR >1.7
- Child-Pugh C cirrhosis
- History or presence of other liver diseases besides PBC
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 196 locations
1
St. Joseph's Hospital and Medical Center - 350 W. Thomas
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
OM Research LLC
Lancaster, California, United States, 93534
Actively Recruiting
3
SCPMG/Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Actively Recruiting
4
Cedar Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
5
California Liver Research Institute
Pasadena, California, United States, 91105
Actively Recruiting
6
Stanford University
Redwood City, California, United States, 94063
Actively Recruiting
7
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
8
California Pacific Medical Center - Sutter Pacific Medical Foundation
San Francisco, California, United States, 94109
Actively Recruiting
9
Connie Frank Transplant Center at UCSF
San Francisco, California, United States, 94143
Actively Recruiting
10
Covenant Metabolic Specialists, LLC
Fort Myers, Florida, United States, 33912
Actively Recruiting
11
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
12
Covenant Metabolic Specialists, LLC
Sarasota, Florida, United States, 33912
Actively Recruiting
13
Florida Research Institute
Tampa, Florida, United States, 34211
Actively Recruiting
14
Piedmont Atlanta Hospital / Piedmont Transplant Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
15
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
16
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
17
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
18
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, United States, 40202
Actively Recruiting
19
Ochsner Clinic Foundation
Jefferson, Louisiana, United States, 70121
Actively Recruiting
20
University Health System - East Jefferson General Hospital Campus
New Orleans, Louisiana, United States, 70112
Actively Recruiting
21
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Actively Recruiting
22
Walter Reed National Military
Bethesda, Maryland, United States, 20889
Actively Recruiting
23
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
24
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
25
Henry Ford Medical Center - Columbus
Detroit, Michigan, United States, 48202
Actively Recruiting
26
University of Rochester Medical Center - Strong Memorial Hospital
Rochester, Minnesota, United States, 14642
Actively Recruiting
27
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, United States, 11030
Actively Recruiting
28
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
29
Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
30
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
31
University Hosptials Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
32
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
33
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
34
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
35
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
36
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
37
UPMC Center for Liver Diseases
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
38
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
39
Gastro One
Cordova, Tennessee, United States, 38018
Actively Recruiting
40
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Actively Recruiting
41
University of Texas Southwestern Medical Center, Professional Office Building One
Dallas, Texas, United States, 75390
Actively Recruiting
42
Soma Clinical Trials
Denison, Texas, United States, 75020
Actively Recruiting
43
American Research Corporation
San Antonio, Texas, United States, 78215
Actively Recruiting
44
Pinnacle Clinical Research, PLLC
San Antonio, Texas, United States, 78229
Actively Recruiting
45
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax
Fairfax, Virginia, United States, 22031
Actively Recruiting
46
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, United States, 23602
Actively Recruiting
47
VCU Health Clinical Research Services Unit (CRSU)
Richmond, Virginia, United States, 23298
Actively Recruiting
48
Liver Institute Northwest
Seattle, Washington, United States, 98105
Actively Recruiting
49
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, 1181
Actively Recruiting
50
Consultorios Médicos Dr. Doreski - PPDS
Buenos Aires, Argentina, 1426
Actively Recruiting
51
Buenos Aires Mácula
Buenos Aires, Argentina, C1061
Actively Recruiting
52
Centro de Investigación y Prevención Cardiovascular
Buenos Aires, Argentina, C1061
Actively Recruiting
53
AES - AS - Glenny Corp. S.A. Buenos Aires
Buenos Aires, Argentina, C1430
Actively Recruiting
54
Higea S.A.
Mendoza, Argentina, M5500
Actively Recruiting
55
DIM Clinica Privada
Ramos Mejía, Argentina, 1704
Actively Recruiting
56
CINME S.A. - Centro de Investigaciones Metabólicas
Recoleta, Argentina, C1118AAT
Actively Recruiting
57
Hospital Provincial Del Centenario
Rosario, Argentina, 2000
Actively Recruiting
58
Princess Alexandra Hospital
Queensland, Queensland, Australia, 4102
Actively Recruiting
59
Flinders Medical Center
Adelaide, South Australia, Australia, 5042
Actively Recruiting
60
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
61
Northern Health
Epping, Victoria, Australia, 3076
Actively Recruiting
62
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
63
Landeskrankenhaus Hall
Hall in Tirol, Austria, 6060
Actively Recruiting
64
Krankenhaus der Barmherzigen Brüder
Vienna, Austria, 1020
Actively Recruiting
65
Medizinische Universität Wien
Vienna, Austria, 1090
Actively Recruiting
66
Klinikum Wels-Grieskirchen GmbH - Standort Wels
Wels, Austria, 4600
Actively Recruiting
67
UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
68
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
69
UZ Leuven - PPDS
Leuven, Belgium, 3000
Actively Recruiting
70
University of Calgary
Calgary, Canada, T2N 4Z6
Actively Recruiting
71
University of Alberta
Edmonton, Canada, T6G 2B7
Actively Recruiting
72
Centre Hospitalier de l'Universite de Montreal
Montreal, Canada, H2L 4M1
Actively Recruiting
73
Ottawa Hospital
Ottawa, Canada, K1H 8L6
Actively Recruiting
74
Diex Recherche - Québec - PPDS
Québec, Canada, G1V 4T3
Actively Recruiting
75
Toronto General Hospital
Toronto, Canada, M5G 2C4
Actively Recruiting
76
GI Research Institute Foundation
Vancouver, Canada, V6G 2Z6
Actively Recruiting
77
Centro de Investigación y Prevención Cardiovascular
La Serena, Chile, 1720506
Actively Recruiting
78
Pontificia Universidad Católica de Chile
Santiago, Chile, 8320000
Actively Recruiting
79
BIOCINETIC Ltda
Santiago, Chile, 8330336
Actively Recruiting
80
Clinical Research Chile SpA - PPDS
Valdivia, Chile, 5110683
Actively Recruiting
81
Beijing Youan Hospital, Capital Medical University
Beijing, China, 100000
Actively Recruiting
82
Beijing Ditan Hospital, Capital Medical University
Beijing, China, 100015
Actively Recruiting
83
Beijing Friendship Hospital, Capital Medical University
Beijing, China, 100050
Actively Recruiting
84
The First Hospital of Jilin University
Changchun, China, 130021
Actively Recruiting
85
West China Hospital of Sichuan University
Chengdu, China, 610047
Actively Recruiting
86
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China, 401336
Actively Recruiting
87
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, China
Actively Recruiting
88
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China, 510630
Actively Recruiting
89
Guizhou Provincial People's Hospital
Guiyang, China, 550002
Actively Recruiting
90
The First Affiliated Hospital of Anhui Medical University
Hefei, China, 230032
Actively Recruiting
91
The First People's Hospital of Yunnan Province
Kunming, China, 650032
Actively Recruiting
92
The Second Hospital of Nanjing
Nanjing, China, 210003
Actively Recruiting
93
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, China, 200001
Actively Recruiting
94
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China, 830054
Actively Recruiting
95
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China, 430030
Actively Recruiting
96
The First Affiliated Hospital of PLA Air Force Medical University
Xi'an, China, 710032
Actively Recruiting
97
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China, 710061
Actively Recruiting
98
The First Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang, China, 310009
Actively Recruiting
99
Henan Provincial People's Hospital
Zhengzhou, China, 450003
Actively Recruiting
100
The Third People's Hospital of Zhenjiang
Zhenjiang, China, 212021
Actively Recruiting
101
Fakultni nemocnice Ostrava
Ostrava, Czechia, 70852
Actively Recruiting
102
RESEARCH Site s.r.o
Pilsen, Czechia, 301 00
Actively Recruiting
103
Aarhus Universitetshospital
Aarhus, Denmark, 8200
Actively Recruiting
104
AP-HP - Hopital Avicenne
Bobigny, France, 93000
Actively Recruiting
105
Hôpital Claude Huriez-Lille-1 Place de Verdun
Lille, France, 59000
Actively Recruiting
106
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
Lyon, France, 69317
Actively Recruiting
107
CHU-Montpellier-Hopital St Eloi
Montipellier, France, 34295
Actively Recruiting
108
Hopital Saint Antoine, Assistance Publique-Hopitaux de Paris
Paris, France, 75012
Actively Recruiting
109
AP-HP Hopital Henri Mondor
Paris, France, 94000
Actively Recruiting
110
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France, 67000
Actively Recruiting
111
CHRU de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
112
Charité Campus Virchow-Klinikum-Augustenburger Platz 1
Berlin, Germany, 13353
Actively Recruiting
113
Universitatsklinikum des Saarlandes
Homburg, Germany, 66421
Actively Recruiting
114
Gastroenterologisch - Hepatologisches MVZ Kiel GmbH
Kiel, Germany, 24146
Actively Recruiting
115
Evangelismos General Hospital
Athens, Greece, 106 76
Actively Recruiting
116
University General Hospital of Larissa
Larissa, Greece, 41 110
Actively Recruiting
117
General Hospital of Thessaloniki ''Hippokratio''
Thessaloniki, Greece, 546 41
Actively Recruiting
118
Prince of Wales Hospital - Hong Kong
Hong Kong, Hong Kong, 000
Actively Recruiting
119
Queen Mary Hospital - PPDS
Hong Kong, Hong Kong, 999077
Actively Recruiting
120
Princess Margaret Hospital - Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
121
Semmelweis Egyetem - Sebészeti,
Budapest, Hungary, 1082
Actively Recruiting
122
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, Hungary, 7400
Actively Recruiting
123
Soroka University Medical Centre
Beersheba, Israel, 84101
Actively Recruiting
124
Lady Davis Carmel Medical Center
Haifa, Israel, 33394
Actively Recruiting
125
Liver Unit, institute of Gasteroenterology and Liver Diseases
Jerusalem, Israel, 91120
Actively Recruiting
126
Tel Aviv Sourasky Medical Center Ichilov
Tel Aviv, Israel, 64239
Actively Recruiting
127
Azienda Ospedaliero Universitaria delle Marche -Umberto I G.M. Lancisi G. Salesi
Ancona, Italy, 60020
Actively Recruiting
128
IRCCS Saverio de Bellis-UOSD "Epatopatie"
Castellana Grotte, Italy, 70013
Actively Recruiting
129
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
130
ASST Santi Paolo Carlo, S.C. Medicina ad Indirizzo Epatologico e Gastroenterologico
Milan, Italy, 20142
Actively Recruiting
131
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Modena, Italy, 41126
Actively Recruiting
132
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy, 20052
Actively Recruiting
133
A.O.U.P. Paolo Giaccone , U.O.C di Gastroeneterologia
Palermo, Italy, 90127
Actively Recruiting
134
A.O.U. Pisana, U.O. Epatologia
Pisa, Italy, 56124
Actively Recruiting
135
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Italy, 71013
Actively Recruiting
136
Clinica de Higado y Gastroenterologia Integral, S.C.
Cuernavaca, Mexico, 62170
Actively Recruiting
137
PROACTIVE CR MEXICO SA de CV
Irapuato, Mexico, 36650
Actively Recruiting
138
Consultorio Medico - Distrito Federal
Mexico City, Mexico, 6700
Actively Recruiting
139
Centro De Investigacion Y Gastroenterogia, S.C.
México, Mexico, 76806
Actively Recruiting
140
Oaxaca Site Management Organization - Hospital - OSMO - PPDS
Oaxaca City, Mexico, 71256
Actively Recruiting
141
FAICIC
Veracruz, Mexico, 91900
Actively Recruiting
142
ID Clinic Arkadiusz Pisula
Mysłowice, Poland, 41-400
Actively Recruiting
143
PlanetMed SP. z. o. o
Wroclaw, Poland, 52-210
Actively Recruiting
144
Galenus Group - Puerto Rico
Manati, Puerto Rico, 00674
Actively Recruiting
145
Institutul Clinic Fundeni
Bucharest, Romania, 022328
Actively Recruiting
146
National University Hospital
Singapore, Singapore, 119228
Actively Recruiting
147
Singapore General Hospital (SGH)
Singapore, Singapore, 308433
Actively Recruiting
148
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Actively Recruiting
149
Changi General Hospital
Singapore, Singapore, 529889
Actively Recruiting
150
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
151
Kyungpook National University Hospital
Daegu, South Korea, 41944
Actively Recruiting
152
Chonnam National University Hospital
Gwangju, South Korea, 61455
Actively Recruiting
153
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Actively Recruiting
154
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
155
Korea University Guro Hospital
Seoul, South Korea, 08308
Actively Recruiting
156
Seoul National University Hospital
Seoul, South Korea, 3080
Actively Recruiting
157
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 3722
Actively Recruiting
158
Samsung Medical Center
Seoul, South Korea, 6351
Actively Recruiting
159
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 6591
Actively Recruiting
160
Complexo Hospitalario Universitario De Santiago
A Coruña, Spain, 15706
Actively Recruiting
161
Hospital Universitario Fundacion Alcorcon
Alcorcón, Spain, 28925
Actively Recruiting
162
Hospital Universitario Germans Trias i Pujol
Badalona, Spain, 08916
Actively Recruiting
163
Hospital del Mar
Barcelona, Spain, 08003
Actively Recruiting
164
Hospital Universitario Vall d'Hebron-VIHR
Barcelona, Spain, 08035
Actively Recruiting
165
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
166
C.H. Regional Reina Sofia - PPDS
Córdoba, Spain, 14004
Actively Recruiting
167
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
168
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Actively Recruiting
169
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain, 41010
Actively Recruiting
170
Universitätsspital Bern
Bern, Switzerland, 3010
Actively Recruiting
171
Universitätsspital Zürich
Zurich, Switzerland, 8091
Actively Recruiting
172
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
173
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Actively Recruiting
174
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
175
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
176
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
177
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, 33305
Actively Recruiting
178
Adana City Training and Research Hospital
Adana, Turkey (Türkiye), 1370
Actively Recruiting
179
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
180
Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital
Gaziantep, Turkey (Türkiye), 27630
Actively Recruiting
181
Uludag University Medical Faculty
Görükle, Turkey (Türkiye), 16059
Actively Recruiting
182
Ege University
Izmir, Turkey (Türkiye), 35040
Actively Recruiting
183
Katip Celebi University
Karabağlar, Turkey (Türkiye), 35150
Actively Recruiting
184
Kocaeli University Medical Faculty Hospital
Kocaeli, Turkey (Türkiye), 41380
Actively Recruiting
185
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, Turkey (Türkiye), 33110
Actively Recruiting
186
Marmara University Pendik Training and Research Hospital
Pendik, Turkey (Türkiye), 34899
Actively Recruiting
187
Rize Recep Tayyip Erdogan University Training and Research Hospital
Rize Merkez, Turkey (Türkiye), 53020
Actively Recruiting
188
Hull Royal Infirmary
Hull, United Kingdom, HU32JZ
Actively Recruiting
189
East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital
Ipswich, United Kingdom, IP4 5PD
Actively Recruiting
190
The Royal London Hospital
London, United Kingdom, E1 1BB
Actively Recruiting
191
Royal Free Hospital
London, United Kingdom, NW2 2QG
Actively Recruiting
192
King's College Hospital
London, United Kingdom, SE5 9RS
Actively Recruiting
193
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
194
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
195
Sheffield teaching hospital NHS foundation trust
Sheffield, United Kingdom, S10 2JF
Actively Recruiting
196
New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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