Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06051617

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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