A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness

PHASE2CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

February 14, 2022

Primary Completion Date

May 31, 2024

Study Completion Date

July 2, 2024

Conditions
Primary Biliary CholangitisLiver Stiffness
Interventions
DRUG

Setanaxib

Oral tablets, 400mg per tablet

DRUG

Placebo

Oral tablets

Trial Locations (128)

1020

Centre Hospitalier Universitaire Brugmann - Site Victor Horta, Laken

1023

Auckland City Hospital, Grafton

1070

Hôpital Erasme, Brussels

1082

Semmelweis Egyetem - I. Sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika, Budapest

2050

Royal Prince Alfred Hospital, Camperdown

2170

Liverpool Hospital, Liverpool

2305

John Hunter Hospital, New Lambton Heights

2747

Nepean Hospital, Kingswood

3000

Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven

3004

The Alfred Hospital, Melbourne

3128

Eastern Health - Australia, Box Hill

3168

Monash Medical Centre, Clayton

3240

Waikato Hospital, Hamilton

4010

Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz

4101

Mater Misericordiae - Hospital Brisbane, South Brisbane

4600

Klinikum Wels-Grieskirchen, Wels

5042

Flinders Medical Centre, Bedford Park

6020

Medizinische Universität Innsbruck, Innsbruck

6021

Wellington Regional Hospital, Crofton Downs

6150

Fiona Stanley Hospital, Murdoch

6900

Fondazione Epatocentro Ticino, Lugano

8036

Universitaetsklinikum Graz - Universitätsklinik für Innere Medizin, Graz

9000

Universitair Ziekenhuis Gent, Ghent

9007

Kantonsspital Sankt Gallen, Sankt Gallen

9016

Dunedin Hospital, Dunedin

10016

New York University Hepatology Associates, New York

10029

Icahn School of Medicine at Mount Sinai, New York

11030

Northwell Health, Manhasset

13008

Hôpital Saint Joseph Marseille, Marseille

14004

Hospital Universitario Reina Sofía, Córdoba

15706

Hospital Clínico Universitario de Santiago, Santiago

19141

Einstein Medical Center, Philadelphia

20089

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas, Rozzano

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

20123

Ospedale San Giuseppe, Milan

20900

Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo, Monza

22100

Western Galilee Hospital-Nahariya, Nahariya

27157

Wake Forest University Baptist Medical Center, Winston-Salem

28006

Hospital Universitario de La Princesa, Madrid

28007

Hospital General Universitario Gregorio Marañón, Madrid

28046

Hospital Universitario La Paz, Madrid

28100

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara, Novara

29010

Hospital Universitario Virgen de la Victoria, Málaga

30625

Medizinische Hochschule Hannover, Hanover

31059

Hôpital Rangueil, Toulouse

31076

Clinique Pasteur - Toulouse, Toulouse

32804

AdventHealth Transplant Institute, Orlando

32825

Advanced Research Institute, Inc., Orlando

33136

University of Miami Leonard M. Miller School of Medicine, Miami

33606

Tampa General Hospital, Tampa

34452

Gastroenterology Associates - Crystal River, Inverness

37232

Vanderbilt Digestive Disease Center, Nashville

38043

Centre Hospitalier Universitaire Grenoble Alpes, Grenoble

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

39216

Summit - Southern Therapy and Advanced Research, Jackson

41011

Hospital Universitario Virgen del Rocío, Seville

41110

University General Hospital of Larissa, Larissa

46014

Consorci Hospital General Universitari de València, Valencia

48109

A. Alfred Taubman Health Care Center, Ann Arbor

48202

Henry Ford Hospital, Detroit

50009

Hospital Universitario Miguel Servet, Zaragoza

52242

University of Iowa Hospitals and Clinics, Iowa City

53226

Froedtert and Medical College of Wisconsin, Milwaukee

54511

Hôpitaux de Brabois, Vandœuvre-lès-Nancy

57701

Rapid City Medical Center, Rapid City

59037

Hôpital Claude Huriez, Lille

Hôpital Claude Huriez, Lille

60020

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ancona

60590

Universitätsklinikum Frankfurt, Frankfurt am Main

60611

Northwestern University, Evanston

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

65189

St. Josefs-Hospital Wiesbaden, Wiesbaden

66421

Universitätsklinikum des Saarlandes, Homburg

66606

Kansas Medical Clinic - Gastroenterology, Topeka

69317

Hôpital de la Croix Rousse, Lyon

70112

Tulane Medical Center, New Orleans

71110

University General Hospital of Heraklion (PAGNI), Heraklion

75012

Hôpital Saint-Antoine, Paris

77030

Liver Specialists of Texas, Houston

77099

Pioneer Research Solutions, Houston

80054

Centre Hospitalier Universitaire Amiens-Picardie - Site Sud, Amiens

80131

Università degli Studi di Napoli Federico II, Napoli

81675

Klinikum rechts der Isar der Technischen Universität München, Munich

84101

Soroka Medical Center, Beersheba

84132

University of Utah Hospital, Salt Lake City

85724

UA Thomas D. Boyer Liver Institute, Tucson

87042

Hopital Dupuytren, Limoges

90048

Cedars-Sinai Medical Center, Los Angeles

91105

California Liver Research Institute, Pasadena

94000

Hôpitaux Universitaires Henri Mondor, Créteil

95817

University of California Davis Medical Center, Sacramento

98124

Azienda Ospedaliera Universitaria Policlinico Gaetano Martino, Messina

3109601

Rambam Health Care Campus, Haifa

3436212

Carmel Medical Center, Haifa

4941492

Rabin Medical Center - Beilinson Hospital, Petah Tikva

9112001

Hadassah University Hospital Ein Kerem, Jerusalem

62794-9248

Springfield Clinic, Springfield

45267-0595

University of Cincinnati, Cincinnati

T2N 4Z6

University of Calgary, Calgary

B3H 3A7

Queen Elizabeth II Health Sciences Centre - Victoria General, Halifax

L8N 4A6

St. Joseph's Healthcare Hamilton - Charlton Campus, Hamilton

N6A 2C2

Centricity Research (LMC Manna Research) - London, London

P1B 2H3

Office Of Stephane M. Gauthier, North Bay

M6H 3M1

Toronto Liver Center, Toronto

H2X 3J4

Centre Hospitalier de l'Université de Montréal (CHUM), Montreal

L6R 3J7

William Osler Health System - Brampton Civic Hospital, Brampton

169 02

Ústřední Vojenská Nemocnice Praha, Prague

500 12

Hepato-Gastroenterologie HK, Hradec Králové

49 933

Centre Hosptitalier Universitaire d'Angers, Angers

06202

Hôpital l'Archet, Nice

04103

Eugastro, Leipzig

41-902

Szpital Specjalistyczny Nr 1 w Bytomiu, Bytom

41-400

ID Clinic, Mysłowice

51-162

Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p., Wroclaw

08916

Hospital Germans Trias i Pujol, Badalona

08208

Hospital de Sabadell, Sabadell

03010

Hospital General Universitari d'Alicante, Alicante

04009

Complejo Hospitalario Torrecárdenas, Almería

08003

Hospital del Mar - Parc de Salut Mar, Barcelona

08036

Hospital Clínic de Barcelona, Barcelona

751 85

Akademiska Sjukhuset - Uppsala, Uppsala

GL1 3NN

Gloucestershire Hospitals NHS Foundation Trust, Gloucester

SE5 9RS

King's College Hospital NHS Foundation Trust, London

NE7 7DN

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

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

S10 2JF

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

SO16 6YD

University Hospital Southampton NHS Foundation Trust, Southampton

G4 0SF

NHS Greater Glasgow and Clyde, Glasgow

All Listed Sponsors
lead

Calliditas Therapeutics Suisse SA

INDUSTRY