RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

PHASE3CompletedINTERVENTIONAL
Enrollment

193

Participants

Timeline

Start Date

April 21, 2021

Primary Completion Date

August 11, 2023

Study Completion Date

August 11, 2023

Conditions
Primary Biliary Cholangitis
Interventions
DRUG

Seladelpar 10 mg

Seladelpar 10 mg one capsule daily for double-blind period, for a duration of up to 12 months

DRUG

Placebo

One capsule daily for double-blind period, for a duration of up to 12 months

DRUG

Seladelpar 5 mg

If down-titration needed, one capsule daily for double-blind period, for a duration of up to 12 months

Trial Locations (134)

1082

Semmelweis Egyetem, Budapest

2139

Concord Repatriation General Hospital, Concord

2650

UZ Antwerpen, Edegem

Hvidovre Hospital, Hvidovre

2910

Hospital Universitario Virgen de la Victoria, Málaga

3000

Universitaire Ziekenhuizen Leuven, Leuven

3004

Alfred Hospital, Melbourne

3050

The Royal Melbourne Hospital, Parkville

4000

CHU de Liège, Liège

4029

Royal Brisbane & Women's Hospital, Herston

4600

Klinikum Wels-Grieskirchen GmbH, Abteilung Fur Innere Medizin I - Gastroenterologie, Wels

7400

Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvár

8011

Gastroenterology, Christchurch Hospital, Christchurch

8091

University of Zurich, Gastroenterology and Hepatology, Zurich

9000

AZ Maria Middelares, Ghent

Universitair Ziekenhuis Gent, Ghent

Aalborg Universitetshospital, Ambulatoriet for Medicinske Mave-Tarm Sygdomme, Aalborg

9016

Gastroenterology Research Unit Dunedin Hospital, Dunedin

10016

NYU Langone Health / NYU Grossman School of Medicine, New York

10021

Weill Cornell Medical College, New York

10029

Icahn School of Medicine at Mount Sinai, New York

13620

Seoul National University Bundang Hospital, Gyeonggi-do

14584

Soon Chun Hyang University Hospital Bucheon, Bucheon-si

14642

University of Rochester Medical Center, Rochester

15213

UPMC Center for Liver Diseases, Pittsburgh

17033

Penn State Milton S Hershey Medical Center, Hershey

20099

Ifi-Medizin GmbH, Hamburg

20900

ASST di Monza, Monza

21202

Mercy Medical Center, Baltimore

23226

Bon Secours Richmond Community Hospital LLC, Richmond

28041

Hospital Universitario 12 de Octubre, Madrid

28358

Care Access Research - Lumberton, Lumberton

30309

Digestive Healthcare of Georgia, Atlanta

33136

Schiff Center for Liver Diseases/University of Miami, Miami

33912

Covenant Metabolic Specialists, LLC, Fort Myers

34093

Bezmi Alem University, Istanbul

34211

Florida Research Institute, Lakewood Rch

34240

Covenant Research and Clinics, LLC, Sarasota

34899

Marmara University Pendik Training and Research Hospital, Istanbul

35100

Ege University Medical Faculty, Izmir

35128

Azienda Ospedaliera Universita Padova, Padua

37212

Vanderbilt Digestive Disease Center, Nashville

37421

Galen Hepatology, Chattanooga

38043

CHU de Grenoble, Grenoble

38138

Gastro One, Germantown

39008

Hospital Universitario Margues de Valdecilla, Santander

39216

Southern Therapy and Advanced Research, LLC (STAR), Jackson

41110

General University Hospital of Larissa Department of Medicine and Research Laboratory of internal rv1edicine, National Expertise Center of Greece in Autoimmune liver Diseases, Larissa

41126

Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara, Bologna

41944

Kyungpook National University Hospital, Daegu

44106

University Hospitals Cleveland Medical Center, Cleveland

44623

Gastroenterologische Gemeinschaftspraxis, Herne

47392

Inje University Busan Paik Hospital, Busan

48377

Henry Ford Health System, Novi

49241

Pusan National University Hospital, Busan

50139

Azienda Ospedaliero Universitaria Careggi, Florence

52140

Consultorio de la Doctora Maria Sarai Gonzalez Huezo, Metepec

52621

Liver Disease Center, Sheba Medical Center, Ramat Gan

53127

Universitätsklinikum Bonn, Bonn

55117

MNGI Digestive Health, P.A., Maplewood

60020

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi, Ancona

60590

Universitatsklinikum Frankfurt. Medizinische Klinik I, Frankfurt am Main

60612

Rush University Medical Center, Chicago

60637

University of Chicago Hospitals, Chicago

61124

"Municipal Non-profit Enterprise City Clinical Hospital #13 of Kharkiv City Council", Kharkiv

63104

Saint Louis University, St Louis

64239

Institute for Digestive Tract & Liver Disease, Tel Aviv

64460

Hospital Universitario Dr. Jose Eleuterio González, Monterrey

66421

Universitätsklinikum des Saarlandes, Homburg

69004

Hopital de la Croix-Rousse, Lyon

70112

Tulane University Health Sciences Center, New Orleans

72205

Arkansas Diagnostic Center, Little Rock

75012

Hopital Saint-Antoine - Service d'Hepato-Gastro-Enterologie -184, rue du Faubourg Saint-Antoine, Paris

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

76104

Texas Digestive Disease Consultants dba GI Alliance, Fort Hood

77030

Baylor College of Medicine, Houston

78215

American Research Corporation at the Texas Liver Institute, San Antonio

78229

Pinnacle Clinical Research, PLLC, San Antonio

85224

The Institute for Liver Health DBA Arizona Liver Health, Chandler

90127

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo

91054

Universitatsklinikum Erlangen, Medizinische Klinik I, Gastroenterologie, Erlangen

91105

California Liver Research Institute, Pasadena

91120

Liver Unit, Jerusalem

94109

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

94305

Stanford University School of Medicine, Palo Alto

95817

University of California, Davis Medical Center, Sacramento

98105

Liver Institute Northwest, Seattle

111123

"State budget institution of healthcare of Moscow city Moscow Clinical Scientific and Practical Centre n. a. A.S. Loginov of Moscow City Healthcare, Department, Central Research Institute of Gastroenterology", Moscow

117198

"Federal State Autonomous Educational Institution of Higher Education Peoples' Friendship University of Russia, Centre of Liver Studies", Moscow

199034

Clinic of High Medical Technologies n.a. N.I. Pirogov, Saint Petersburg

355017

Stavropol state medical university, Stavropol

432063

Ulyanovsk Regional Clinical Hospital, Ulyanovsk

443045

"LLC Medical Company Hepatolog", Samara

1700000

Centro Clinico Mediterraneo, La Serena

2540364

Centro de Investigaciones Clínicas Vina del Mar, Valparaíso

5110683

Clinical Research Chile SpA, Valdivia

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

C1426ABP

Centro Medico Dra. De Salvo, CABA

C1023AAB

STAT Research S.A., Ciudad Autonoma de Buenos Aire

B1900AX

Hospital Italiano de La Plata, La Plata

B1704ETD

DIM CliniaPrivada, Ramos Mejía

C1056ABJ

CINME (Centro de Investigaciones Metabolicas), Buenos Aires

C1199ABB

Hospital Italiano de Buenos Aires, Caba

N6A 5A5

London Health Sciences Centre, London

M5G 2C4

University Health Network, Toronto

L4L 4Y7

Toronto Digestive Disease Associates Inc, Vaughan

708 52

Fakultni nemocnice Ostrava- Interni a Kardiologicka Klinika, Oddeleni gastroenterologie, hepatologie a pankreatologie, Ostrava

04103

Universitatsklinikum Leipzig, Leipzig

115 27

Ippokrateio General Hospital of Athens, Athens

06100

Campeche No. 280, Int. 601 y 602, Col. Hipodromo, Cuauhtemoc, Mexico City

06700

Consultorio Medico - Distrito Federal, Mexico City

40-752

Uniwersyteckie Centrum Kliniczne Im., Katowice

41-400

ID Clinic Akradiusz Pisula, Mysłowice

022328

Fundeni Clinical Institute, Bucharest

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

03722

Severance Hospital Yonsei University Health System - PPDS, Soeul

08916

Hospital Universitario German Trias i Pujol, Badalona

08035

Hospital Universitario Vall D'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

06560

Ankara Gazi University Faculty of Medicine Hospital, Ankara

06800

Ankara Sehir Hastanesi, Ankara

0291

Medical Center OK!Clinic+LLC International Institute of Clinical Research, Kyiv

PL6 8DH

University Hospitals Plymouth NHS Trust, Plymouth

P06 3LY

Portsmouth Hospitals NHS Trust, Portsmouth

E1 1RF

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

NG7 2UH

Queen's Medical Centre, Nottingham

OX4 2LL

Gemini Clinical Trial Unit, Oxford

B15 2TH

University Hospitals Birmingham NHS Foundation Trust, Heritage Building (Queen Elizabeth Hospital), Birmingham

HU3 2JZ

Hull Royal Infirmary, Hull

SE5 9RS

Kings College Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY