Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

December 12, 2017

Primary Completion Date

November 30, 2028

Study Completion Date

November 30, 2028

Conditions
Primary Biliary Cirrhosis
Interventions
DRUG

Seladelpar 5 mg Capsule

Subjects will be assigned to a treatment group if tolerability issues noted in the previous study.

DRUG

Seladelpar 10 mg Capsule

Subjects will be assigned to a treatment group unless there are tolerability issues.

Trial Locations (108)

1082

Semmelweis Egyetem, Budapest

1181

Hospital Italiano de Buenos Aires, Buenos Aires

1684

DIM Clínica Privada, El Palomar

3000

UZ Leuven, Leuven

3004

The Alfred Hospital, Melbourne

3050

Royal Melbourne Hospital, Parkville

4029

Royal Brisbane and Women's Hospital, Herston

4710

Klinikum Wels-Grieskirchen GmbH - Standort Wels, Wels

Christchurch Hospital, Christchurch

6590

Gazi University Faculty of Medicine, Ankara

7400

Somogy Varmegyei Kaposi Mor Oktato Korhaz, Kaposvár

8036

Hospital Clinic de Barcelona, Barcelona

8091

Universitätsspital Zürich, Zurich

9000

UZ Gent, Ghent

9012

Dunedin Hospital, Dunedin

10021

NYU Langone Medical Center, New York

Weill Cornell Medical College, New York

10029

Icahn School of Medicine at Mount Sinai, New York

10117

Charité - Universitätsmedizin Berlin, Berlin

13620

Seoul National University Bundang Hospital, Seongnam

14584

Soon Chun Hyang University Hospital Bucheon, Bucheon-si

14642

University of Rochester Medical Center - PPDS, Rochester

15213

University of Pittsburgh Medical Center, Pittsburgh

17033

Penn State Health Milton S. Hershey Medical Center, Hershey

18017

Northeast Clinical Research Center, LLC, Bethlehem

20089

Fondazione IRCCS San Gerardo dei Tintori, Rozzano

20099

ifi-Institute for Interdisciplinary Medicine, Hamburg

21202

Mercy Medical Center (Baltimore), Baltimore

22328

Fundeni Clinical Institute, Bucharest

23226

Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond, Richmond

23602

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

24146

Gastroenterologisch Hepatologisches Zentrum Kiel - Preetzer Chaussee 134, Kiel

27710

Duke University Medical Center, Durham

28026

Hospital Universitario 12 de Octubre, Madrid

28755

Hospital Universitario La Paz - PPDS, Horcajo de la Sierra

29010

Hospital Universitario Virgen de la Victoria, Málaga

30309

Digestive Healthcare of Georgia PC, Atlanta

33136

University of Miami Miller School of Medicine, Miami

33606

Covenant Research Fort Myers, Fort Myers

33912

Covenant Research, LLC, Sarasota

34093

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi, Topkapı

34211

Florida Digestive Health Specialist, Lakewood Rch

34462

Carmel Medical Center, Haifa

34840

Marmara University Pendik Training and Research Hospital, Maltepe

35100

Ege Universitesi Tip Fakultesi Hastanesi, Bornova

37212

Vanderbilt University Medical Center, Nashville

37404

Galen Medical Group, Chattanooga

38018

Gastro One-8110 Walnut Run Rd, Cordova

39008

Hospital Universitario Marques de Valdecilla, Santander

39090

University of Texas Southwestern Medical Center, Dallas

39157

Southern Therapy and Advanced Research LLC, Jackson

41126

Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara, Modena

41944

Kyungpook National University Hospital, Daegu

44623

Gastroenterologische Gemeinschaftspraxis Herne, Herne

47392

Inje University Busan Paik Hospital, Busan

48377

Henry Ford Health System, Novi

49241

Pusan National University Hospital, Busan

52120

Consultorio de la Doctora Maria Sarai Gonzalez Huezo, Metepec

55413

MNGI Digestive Health PA-Plymouth, Minneapolis

60637

University of Chicago Hospitals, Chicago

63104

Saint Louis University, St Louis

69004

Hospices Civils de Lyon - Hôpital de La Croix Rousse, Lyon

70112

East Jefferson General Hospital, New Orleans

72076

Universitätsklinikum Tübingen, Tübingen

72205

Arkansas Diagnostic Center, Little Rock

75012

AP-HP - Hôpital Saint Antoine, Paris

75203

Liver Institute at Methodist Dallas, Dallas

77030

Baylor College of Medicine, Houston

78229

Pinnacle Clinical Research, PLLC, San Antonio

80045

University of Colorado - Denver - PPDS, Aurora

90127

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Palermo-Piazza Delle Cliniche 2, Palermo

91054

Universitatsklinkum Erlangen-Ulmenweg 18, Erlangen

91105

California Liver Research Institute, Pasadena

91120

Hadassah Medical Center- Ein Kerem - PPDS, Jerusalem

94115

California Pacific Medical Center, San Francisco

94305

Stanford University School of Medicine, Palo Alto

95817

University of California Davis Medical Center, Sacramento

98195

Liver Institute Northwest, PLLC, Seattle

1720506

Centro Clinico Mediterraneo, La Serena

5262100

The Chaim Sheba Medical Center - PPDS, Tel Aviv

6423906

Tel Aviv Sourasky Medical Center Ichilov - PPDS, Tel Aviv

06510

Yale University School of Medicine, New Haven

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center - 330 Brookline Ave, Boston

78215 1619

The Texas Liver Institute - 607 Camden St, San Antonio

C1056ABJ

CINME S.A. - Centro de Investigaciones Metabólicas-Viamonte 2278, Balvanera

B1902AWL

Hospital Italiano de La Plata, La Plata

T2N 4Z6

University of Calgary Medicine, Calgary

M5G 2C4

Toronto General Hospital, Toronto

708 00

Fakultni nemocnice Ostrava, Ostrava

411 10

University General Hospital of Larissa, Larissa

06700

Consultorio Medico - Distrito Federal, Roma Norte

6525 GA

Radboud Universitair Medisch Centrum, Nijmegen

40-752

Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi, Katowice

41-400

ID Clinic Arkadiusz Pisula, Mysłowice

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Songpa-Gu

08916

Hospital Universitario Germans Trias i Pujol, Badalona

08035

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

06800

Ankara Bilkent City Hospital, Çankaya

B15 2TH

Queen Elizabeth Hospital Birmingham, Birmingham

HU3 2JZ

Hull Royal Infirmary, Hull

E1 1BB

Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre, London

SE5 9RS

King's College Hospital, London

NE4 6BE

The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

NG7 2UH

Queen's Medical Centre, Nottingham

PL6 8DH

Derriford Hospital, Plymouth

PO6 3LY

Queen Alexandra Hospital, Portsmouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT03301506 - Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) | Biotech Hunter | Biotech Hunter