Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

PHASE3RecruitingINTERVENTIONAL
Enrollment

318

Participants

Timeline

Start Date

September 7, 2023

Primary Completion Date

August 31, 2030

Study Completion Date

August 31, 2030

Conditions
Primary Biliary Cholangitis
Interventions
DRUG

Seladelpar

"* Seladelpar 10 mg one capsule daily for up to 36 months in participants with CP-A cirrhosis or~* Seladelpar 5 mg one capsule daily for up to 36 months in participants with CP-B cirrhosis."

DRUG

Placebo

One capsule daily for up to 36 months.

Trial Locations (110)

1020

RECRUITING

Krankenhaus der Barmherzigen Brüder, Vienna

1181

RECRUITING

Hospital Italiano de Buenos Aires, Buenos Aires

1370

RECRUITING

Adana City Training and Research Hospital, Adana

1426

RECRUITING

Consultorios Médicos Dr. Doreski - PPDS, Buenos Aires

1704

RECRUITING

DIM Clinica Privada, Ramos Mejía

2650

RECRUITING

UZ Antwerpen, Edegem

3004

RECRUITING

Alfred Hospital, Melbourne

3010

RECRUITING

Universitätsspital Bern, Bern

3076

RECRUITING

Northern Health, Epping

3080

RECRUITING

Seoul National University Hospital, Seoul

3168

RECRUITING

Monash Health, Monash Medical Centre, Clayton

3722

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

4102

RECRUITING

Princess Alexandra Hospital, Queensland

4600

RECRUITING

Klinikum Wels-Grieskirchen GmbH - Standort Wels, Wels

5042

RECRUITING

Flinders Medical Center, Adelaide

6351

RECRUITING

Samsung Medical Center, Seoul

6700

RECRUITING

Consultorio Medico - Distrito Federal, Mexico City

7400

RECRUITING

Somogy Varmegyei Kaposi Mor Oktato Korhaz, Kaposvár

8091

RECRUITING

Universitätsspital Zürich, Zurich

8200

RECRUITING

Aarhus Universitetshospital, Aarhus

9000

RECRUITING

UZ Gent, Ghent

10016

RECRUITING

NYU Langone Health, New York

10029

RECRUITING

Mount Sinai, New York

11030

RECRUITING

Northwell Health Center for Liver Disease and Transplantation, Manhasset

13353

RECRUITING

Charité Campus Virchow-Klinikum-Augustenburger Platz 1, Berlin

13620

RECRUITING

Seoul National University Bundang Hospital, Seongnam

14004

RECRUITING

C.H. Regional Reina Sofia - PPDS, Córdoba

15213

RECRUITING

UPMC Center for Liver Diseases, Pittsburgh

16059

RECRUITING

Uludag University Medical Faculty, Görükle

17033

RECRUITING

Penn State Health Milton S. Hershey Medical Center, Hershey

19107

RECRUITING

Thomas Jefferson University, Philadelphia

20142

RECRUITING

ASST Santi Paolo Carlo, S.C. Medicina ad Indirizzo Epatologico e Gastroenterologico, Milan

21202

RECRUITING

Mercy Medical Center, Baltimore

22031

RECRUITING

MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax, Fairfax

23298

RECRUITING

VCU Health Clinical Research Services Unit (CRSU), Richmond

23602

RECRUITING

Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads, Newport News

27157

RECRUITING

Wake Forest Baptist Medical Center, Winston-Salem

27630

RECRUITING

Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital, Gaziantep

29010

RECRUITING

Hospital Universitario Virgen de la Victoria, Málaga

30309

RECRUITING

Piedmont Atlanta Hospital / Piedmont Transplant Institute, Atlanta

33110

RECRUITING

Mersin Universitesi Tip Fakultesi Hastanesi, Mersin

33136

RECRUITING

Schiff Center for Liver Diseases/University of Miami, Miami

33912

RECRUITING

Covenant Metabolic Specialists, LLC, Fort Myers

RECRUITING

Covenant Metabolic Specialists, LLC, Sarasota

34211

RECRUITING

Florida Research Institute, Tampa

34295

RECRUITING

CHU-Montpellier-Hopital St Eloi, Montipellier

34899

RECRUITING

Marmara University Pendik Training and Research Hospital, Pendik

35040

RECRUITING

Ege University, Izmir

35150

RECRUITING

Katip Celebi University, Karabağlar

38018

RECRUITING

Gastro One, Cordova

39008

RECRUITING

Hospital Universitario Marques de Valdecilla, Santander

40202

RECRUITING

University of Louisville, Clinical Trials Unit, Louisville

41380

RECRUITING

Kocaeli University Medical Faculty Hospital, Kocaeli

41944

RECRUITING

Kyungpook National University Hospital, Daegu

44106

RECRUITING

University Hosptials Cleveland Medical Center, Cleveland

48202

RECRUITING

Henry Ford Medical Center - Columbus, Detroit

49241

RECRUITING

Pusan National University Hospital, Busan

52242

RECRUITING

University Of Iowa Hospitals And Clinics, Iowa City

53020

RECRUITING

Rize Recep Tayyip Erdogan University Training and Research Hospital, Rize Merkez

56124

RECRUITING

A.O.U. Pisana, U.O. Epatologia, Pisa

59000

RECRUITING

Hôpital Claude Huriez-Lille-1 Place de Verdun, Lille

60637

RECRUITING

University of Chicago Medical Center, Chicago

61455

RECRUITING

Chonnam National University Hospital, Gwangju

62170

RECRUITING

Clinica de Higado y Gastroenterologia Integral, S.C., Cuernavaca

67000

RECRUITING

CHU de Strasbourg - Nouvel Hôpital Civil, Strasbourg

69317

RECRUITING

Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse, Lyon

70013

RECRUITING

"IRCCS Saverio de Bellis-UOSD Epatopatie", Castellana Grotte

70112

RECRUITING

University Health System - East Jefferson General Hospital Campus, New Orleans

70121

RECRUITING

Ochsner Clinic Foundation, Jefferson

71256

RECRUITING

Oaxaca Site Management Organization - Hospital - OSMO - PPDS, Oaxaca City

75020

RECRUITING

Soma Clinical Trials, Denison

75203

RECRUITING

The Liver Institute at Methodist Dallas Medical Center, Dallas

75390

RECRUITING

University of Texas Southwestern Medical Center, Professional Office Building One, Dallas

76806

RECRUITING

Centro De Investigacion Y Gastroenterogia, S.C., México

78215

RECRUITING

American Research Corporation, San Antonio

78229

RECRUITING

Pinnacle Clinical Research, PLLC, San Antonio

90027

RECRUITING

SCPMG/Kaiser Permanente Los Angeles Medical Center, Los Angeles

90048

RECRUITING

Cedar Sinai Medical Center, Los Angeles

90127

RECRUITING

A.O.U.P. Paolo Giaccone , U.O.C di Gastroeneterologia, Palermo

91105

RECRUITING

California Liver Research Institute, Pasadena

93534

RECRUITING

OM Research LLC, Lancaster

94109

RECRUITING

California Pacific Medical Center - Sutter Pacific Medical Foundation, San Francisco

94143

RECRUITING

Connie Frank Transplant Center at UCSF, San Francisco

95817

RECRUITING

University of California, Davis Medical Center, Sacramento

98105

RECRUITING

Liver Institute Northwest, Seattle

1720506

RECRUITING

Centro de Investigación y Prevención Cardiovascular, La Serena

5110683

RECRUITING

Clinical Research Chile SpA - PPDS, Valdivia

8320000

RECRUITING

Pontificia Universidad Católica de Chile, Santiago

8330336

RECRUITING

BIOCINETIC Ltda, Santiago

02114

RECRUITING

Massachusetts General Hospital, Boston

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

C1061

RECRUITING

Buenos Aires Mácula, Buenos Aires

RECRUITING

Centro de Investigación y Prevención Cardiovascular, Buenos Aires

C1430

RECRUITING

AES - AS - Glenny Corp. S.A. Buenos Aires, Buenos Aires

M5500

RECRUITING

Higea S.A., Mendoza

C1118AAT

RECRUITING

CINME S.A. - Centro de Investigaciones Metabólicas, Recoleta

H2L 4M1

RECRUITING

Centre Hospitalier de l'Universite de Montreal, Montreal

K1H 8L6

RECRUITING

Ottawa Hospital, Ottawa

V6G 2Z6

RECRUITING

GI Research Institute Foundation, Vancouver

301 00

RECRUITING

RESEARCH Site s.r.o, Pilsen

41-400

RECRUITING

ID Clinic Arkadiusz Pisula, Mysłowice

52-210

RECRUITING

PlanetMed SP. z. o. o, Wroclaw

022328

RECRUITING

Institutul Clinic Fundeni, Bucharest

05505

RECRUITING

Asan Medical Center, Seoul

08916

RECRUITING

Hospital Universitario Germans Trias i Pujol, Badalona

08003

RECRUITING

Hospital del Mar, Barcelona

08035

RECRUITING

Hospital Universitario Vall d'Hebron-VIHR, Barcelona

08036

RECRUITING

Hospital Clinic de Barcelona, Barcelona

06800

RECRUITING

Ankara Bilkent City Hospital, Ankara

E1 1BB

RECRUITING

The Royal London Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY