Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.

PHASE2CompletedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

June 26, 2017

Primary Completion Date

April 11, 2019

Study Completion Date

April 11, 2019

Conditions
Primary Biliary Cirrhosis
Interventions
DRUG

GKT137831

GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily.

DRUG

Placebo oral capsule

Matching capsules.

Trial Locations (61)

1070

CUB Hôpital Erasme, Brussels

3000

UZ Leuven, Leuven

3906

Sourasky Tel-Aviv Medical Center, Tel Aviv

8036

Hospital Clinic de Barcelona, Barcelona

9000

UZ Gent, Ghent

10016

NYU Hepatology Associates, New York

10029

Mount Sinai Health System, New York

11030

North Shore University Hospital, Manhasset

11527

"General Hospital of Athens Hippocratio", Athens

Laiko General Hospital, Athens

14642

University of Rochester Medical Centre, Rochester

15213

UPMC Center for Liver Diseases, Pittsburgh

20007

MedStar Georgetown University Hospital, Washington D.C.

20900

University of Milan-Bicocca, Monza

23226

Bon Secours Liver Institute of Richmond, Richmond

23602

Bon Secours Liver Institute of Hampton Roads, Newport News

28222

Hospital Puerta de Hierro-Majadahonda, Madrid

28223

University of Alcalá, Madrid

29015

Virgen De La Victoria University Hospital, Málaga

33136

University of Miami, Miami

35128

University Hospital Padova, Padua

38104

Methodist University Hospital, Memphis

39216

Jackson Liver and GI Specialist c/o (STAR) LLC, Jackson

40138

Policlinico of Bologna, Bologna

41013

Hospital Universitario Virgen del Rocio, Seville

41100

University Hospital of Larissa, Larissa

44106

University Hospitals Cleveland Medical Center, Cleveland

45440

Dayton Gastroenterology Inc., Beavercreek

49100

Rabin Medical Centre, Petach-Tiqva

52621

Sheba Medical Centre, Ramat Gan

53105

Universitatsklinikum Bonn, Bonn

60126

Università Politecnica delle Marche - Facoltà di Medicina e Chirurgia, Ancona

60590

Johann Wolfgang Goethe-University, Frankfurt am Main

60611

Northwestern University, Chicago

70112

Tulane University Medical Center, New Orleans

71013

San Giovanni Rotondo Hospital (Puglia), Foggia

77030

St Lukes Episcopal Hospital, Houston

78233

Pinnacle Clinical Research, PLLC, Live Oak

85054

Mayo Clinic, Phoenix

91054

Friedrich-Alexander University Erlangen-Nürnberg, Erlangen

91120

Hadassah Medical Organization, Jerusalem

93003

Ventura Clinical Trials, Ventura

95817

University California Davis, Sacramento

3109601

Rambam Health Centre, Haifa

9103102

Shaare Zedek Medical Center, Jerusalem

06520-8019

Yale School of Medicine, New Haven

T2N4z6

University of Calgary Liver Unit, Calgary

R3E3P4

University of Manitoba, Winnipeg

H2X0A9

Centre hospitalier de l'Universite de Montreal (CHUM) Centre de Recherche Service d'Hepatologie, Montreal

H4A3J1

McGill University Health Centre (MUHC), Montreal

D-69210

Universitätsklinikum Heidelberg, Heidelberg

D-55131

Universitätsmedizin Mainz, Mainz

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

PL6 8DH

Plymouth Hospital NHS Trust, Plymouth

HU3 2JZ

Hull and East Yorkshire Hospitals NHS Trust, Hull

GL13NN

Gloucestershire Royal Hospital, Gloucester

OX3 9DU

Oxford University Hospitals NHS Foundation Trust, Oxford

DD19SY

Tayside Medical Science Centre (TASC), Dundee

B152GW

University Hospitals Birmingham NHS Foundation Trust, Birmingham

SE5 9RS

King's College Hospital NHS Foundation Trust, London

SA28PP

Singleton Hospital, Swansea

Sponsors
All Listed Sponsors
lead

Calliditas Therapeutics AB

INDUSTRY

NCT03226067 - Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol. | Biotech Hunter | Biotech Hunter