A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis

PHASE2CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

December 27, 2017

Primary Completion Date

December 19, 2019

Study Completion Date

January 16, 2020

Conditions
Primary Biliary Cholangitis
Interventions
DRUG

EDP-305 1 mg

Two tablets daily for 12 weeks

DRUG

EDP-305 2.5 mg

Two tablets daily for 12 weeks

DRUG

Placebo

Two tablets daily for 12 weeks

Trial Locations (86)

2747

Nepean Hospital, Kingswood

3168

Monash Medical Centre, Clayton

3600

Ziekenhuis Oost-Limburg, Genk

4000

CHU de Liège, Cardiology Dept., Liège

4600

Klinikum Wels-Grieskirchen, Wels

6000

Linear Clinical Research, Perth

6020

Medizinische Universität Innsbruck, Innsbruck

9000

Universitair Ziekenhuis Gent, Ghent

9020

Klinikum Klagenfurt Am Wörthersee, Klagenfurt

10016

Concorde Medical Group, New York

Mount Sinai Beth Isreal, New York

10024

Weill Cornell Medical College, New York

10029

Icahn School of Medicine at Mount Sinai, New York

11030

Northwell Health, Manhasset

13353

Charité Universitätsmedizin Berlin, Berlin

15213

University of Pittsburgh Medical Center - Center for Liver Disease, Pittsburgh

20014

Hospital Universitario Donostia, Donostia / San Sebastian

21202

Mercy Medical Center-McAuley Plaza, Baltimore

21228

Digestive Disease Associates, Catonsville

21287

Johns Hopkins University, Baltimore

23602

Liver Institute of Virginia-Bremo, Richmond

28034

Hospital Universitario Ramón Y Cajal, Madrid

30120

Hospital Universitario Virgen de la Arrixaca, El Palmar

30312

Consultative Gastroenterology, Atlanta

33136

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

33600

Hôpital Haut-Lévêque, Pessac

34295

Hôpital Saint-Eloi, Montpellier

34452

Nature Coast Clinical Research, Inverness

36305

Digestive Health Specialists of the Southeast, Dothan

39008

Hospital Universitario Marqués de Valdecilla, Santander

41013

Hospital Universitario Virgen del Rocio, Seville

45122

Universitaetsklinikum Essen, Essen

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

47010

Universidad de Valladolid - Hospital Universitario Rio Hortega, Valladolid

48377

Henry Ford Hospital, Detroit

52242

University of Iowa Hospitals and Clinics, Iowa City

53127

Universitätsklinikum Bonn, Bonn

55131

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz

59037

Centre Hospitalier Régional Universitaire de Lille, Lille

60590

Universitätsklinikum Frankfurt, Frankfurt am Main

60611

Northwestern University, Chicago

67091

Nouvel Hôpital Civil, Strasbourg

68124

CHI Health, Omaha

69317

Hôpital de la Croix Rousse, Lyon

71105

Louisiana Research Center, Shreveport

72205

Arkansas Diagnostic Center, Little Rock

75012

Hôpital Saint-Antoine, Paris

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

76012

Texas Clinical Research Institute, Little Rock

76104

Liver Consultants of Texas, Dallas

77030

Baylor Saint Luke's Medical Center, Houston

78215

American Research Corporation at the Texas Liver Institute, San Antonio

80054

Centre Hospitalier Universitaire Amines-Picardie Hôpital Sud, Amiens

80113

South Denver Gastroenterology - Swedish Medical Center Office, Englewood

90048

Cedars-Sinai Medical Center, Los Angeles

91105

California Liver Research Institue, Pasadena

Pasadena Liver Center, Pasadena

92118

Southern California Research Center, Coronado

92377

Inland Empire Liver Foundation, Rialto

94115

California Pacific Medical Center, San Francisco

94800

Hôpital Paul Brousse, Villejuif

97080

Universitätsklinikum Würzburg, Würzburg

98104

Swedish First Hill Campus, Seattle

06520

Yale School of Medicine, New Haven

33756-3839

Gastroenterology Consultants of Clearwater, Clearwater

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

03756

Dartmouth-Hitchcock Medical Center, Lebanon

10461-1925

Montefiore Medical Center - Bronx, The Bronx

98195-6460

University of Washington, Seattle

N6A 5A5

London Health Sciences Centre University Hospital, London

M5G 2C4

Toronto General Hospital, Toronto

M6H 3M1

Toronto Liver Center, Toronto

04103

Universitätsklinikum Leipzig, Leipzig

1081 HV

Vrije Universiteit Medisch Centrum, Amsterdam

2333 ZA

Leiden Universitair Medisch Centrum, Leiden

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

08029

Hospital Universitari Vall d'Hebrón, Barcelona

B15 2TT

University Hospitals Birmingham NHS Foundation Trust, Birmingham

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

LS9 7TF

The Leeds Teaching Hospitals NHS Trust, Leeds

SE5 9RS

King's College Hospital NHS Foundation Trust, London

NR4 7UY

Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich

NG7 2UH

Queen's Medical Centre - Nottingham, Nottingham

PO6 3LY

Portsmouth Hospitals NHS Trust, Portsmouth

EH16 4SA

NHS Lothian, Edinburgh

All Listed Sponsors
collaborator

Pharmaceutical Research Associates

OTHER

collaborator

Triangle Biostatistics, LLC

INDUSTRY

lead

Enanta Pharmaceuticals, Inc

INDUSTRY