A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

PHASE2RecruitingINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

September 22, 2021

Primary Completion Date

April 30, 2027

Study Completion Date

July 31, 2027

Conditions
Primary Biliary CholangitisPBC
Interventions
DRUG

Volixibat

Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.

DRUG

Placebo

Capsules matched to study drug without the active pharmaceutical ingredient

Trial Locations (105)

1200

RECRUITING

Cliniques Universitaires Saint-Luc, Brussels

1430

RECRUITING

Glenny Corp S.A, CABA

1888

RECRUITING

Hospital de Alta Complejidad En Red El Cruce, San Juan Bautista

2000

RECRUITING

Hospital Provincial Del Centenario, Rosario

2650

RECRUITING

Universitair Ziekenhuis Antwerpe UZA, Antwerp

8091

RECRUITING

University Hospital Zurich(USZ), Zurich

9000

RECRUITING

UZ Gent, Ghent

10050

RECRUITING

Beijing Friendship Hospital, Capital Medical University, Beijing

19141

RECRUITING

Einstein Healthcare Network - Einstein Medical Center, Philadelphia

20122

RECRUITING

Fondazione Ca Granda, Milan

20162

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda, Milan

20900

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori, Monza

22031

RECRUITING

MedStar Health Research Institute, Fairfax

23226

RECRUITING

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

23602

RECRUITING

Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital, Newport News

24105

RECRUITING

Universitätsklinikum Schleswig-Holstein, Kiel

27560

RECRUITING

Science 37, Inc (Remote-homebased Telemedicine), Morrisville

28007

RECRUITING

Hospital General Universitario Gregorio Maranon, Madrid

30625

RECRUITING

Medizinische Hochschule Hannover (MHH), Hanover

30720

RECRUITING

Southeast Clinical Research Center, Dalton

32209

RECRUITING

UF Health Gastroenterology- Emerson, Jacksonville

32610

RECRUITING

UF Hepatology Research at CTRB, Gainesville

33136

RECRUITING

Schiff Center for Liver Diseases, Miami

33606

RECRUITING

Tampa General Hospital, Tampa

33912

RECRUITING

Covenant Metabolic Specialists, Fort Myers

34240

RECRUITING

Covenant Research and Clinics, LLC, Sarasota

34653

RECRUITING

Advanced Research Institute, Inc, New Port Richey

34741

TERMINATED

IHS Health, Kissimmee

35128

RECRUITING

Azienda Ospedale-Università di Padova, Padua

37343

RECRUITING

Galen Medical Group, P.C, Tennessee City

38043

RECRUITING

CHU Grenoble - Hôpital MICHALLON, Grenoble

38104

TERMINATED

Methodist Le Bonheur Healthcare, Memphis

39216

TERMINATED

Jackson Liver and GI Specialists, Jackson

41013

RECRUITING

Hospital Universitario Virgen del Rocio, Seville

44195

RECRUITING

Cleveland Clinic - Main Campus, Cleveland

48149

RECRUITING

University Hospital Munster, Münster

52242

RECRUITING

University of Iowa Hospitals & Clinics, Iowa City

52621

RECRUITING

Sheba Medical Center, Ramat Gan

55905

RECRUITING

Mayo Clinic, Rochester

56124

RECRUITING

Azienda Ospedaliero Universitaria Pisana (AOUP), Pisa

59037

RECRUITING

Hopital Claude Huriez-Digestive system disease clinic, Lille

60153

RECRUITING

Loyola University Health System - Loyola Outpatient Center, Maywood

60611

RECRUITING

Northwestern University, Chicago

65189

RECRUITING

St. Josefs-Hospital Wiesbaden, Wiesbaden

67091

RECRUITING

Nouvel Hospital Civil, Strasbourg

68124

RECRUITING

CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan, Omaha

70836

RECRUITING

Ochsner Clinic Foundation-Baton Rouge, Baton Rouge

71103

RECRUITING

LSU Health Science Center Shreveport, Shreveport

72076

RECRUITING

University Hospital Tübingen Medical clinic, Tübingen

75012

RECRUITING

Hospital Saint Antoine, Paris

75020

RECRUITING

Soma Clinical Trials, Denison

76710

RECRUITING

Velocity Clinical Research, Waco

77030

RECRUITING

Baylor College of Medicine, Houston

RECRUITING

Liver Associates of Texas, Houston

78750

RECRUITING

Amel Med LLC, Austin

80045

RECRUITING

University of Colorado, Aurora

84132

RECRUITING

University of Utah Health Care, Salt Lake City

90048

RECRUITING

Cedars Sinai Medical Center, Los Angeles

92218

TERMINATED

Southern California Research Center, Coronado

94800

RECRUITING

Hospital Paul Brousse- APHP, Villejuif

98105

RECRUITING

Liver Institute Northwest, Seattle

100069

RECRUITING

Beijing Youan Hospital, Capital Medical University, Beijing

130031

RECRUITING

The First Hospital of Jilin University, Changchun

310003

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

310009

RECRUITING

Sir Run Run Shaw Hospital -Zhejiang University School of Medicine, Hangzhou

350028

RECRUITING

Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou

430022

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

2210001

RECRUITING

Galilee Medical Center, Nahariya

3109601

RECRUITING

Rambam Medical Center, Haifa

3434104

RECRUITING

Carmel Medical Center, Haifa

3810101

RECRUITING

Hillel Yaffe Medical Center, Hadera

4941492

RECRUITING

Rabin Medical Center, Petah Tikva

6423906

TERMINATED

The Tel Aviv Sourasky Medical Center, Tel Aviv

9103102

TERMINATED

Shaare Zedek Medical Center, Jerusalem

9112001

RECRUITING

Hadassah Medical Center - Ein Karem, Liver Institute Kiryat Hadassah POB 12000, Jerusalem

90035903

RECRUITING

Hospital de Clínicas de Porto Alegre, Porto Alegre

02215

RECRUITING

Beth Israel Deaconess, Boston

40290-000

RECRUITING

Centro de Pesquisa Clínica da Bahiana Saúde, Salvador

74605-050

RECRUITING

Hospital Das Clínicas Da Ufg, Goiânia

30130-100

RECRUITING

Centro de Pesquisas Clínicas do HC/UFMG-EBSERH, Belo Horizonte

04038-002

RECRUITING

Fundação Oswaldo Ramos, São Paulo

V5Z 1M9

RECRUITING

Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology, Vancouver

L8S 4K1

RECRUITING

McMaster University Medical Center, Hamilton

N6A5A5

RECRUITING

University Hospital, LHSC, London

H4A 3J1

RECRUITING

McGill University Health Centre, Montreal

T6G 2X8

RECRUITING

University of Alberta, Edmonton

06202

RECRUITING

CHU de NICE- Hospital L'Archet 2, Nice

09116

RECRUITING

Klinikum Chemnitz gGmbH, Chemnitz

Unknown

RECRUITING

Universitätsklinikum Frankfurt am Main, Frankfurt

RECRUITING

Universita Politecnica delle Marche- Ospedali Riuniti, Ancona

RECRUITING

Istituto Clinico Humanitas, Rozzano

RECRUITING

Erasmus medical center, Rotterdam

RECRUITING

Nottingham University Hospitals NHS Trust, Nottingham

856-8562

RECRUITING

National Hospital Organization Nagasaki Medical Center, Ōmura

791-0295

RECRUITING

Ehime University Hospital, Ehime

006-8555

RECRUITING

Teine Keijinkai Hospital, Hokkaido

591-8025

RECRUITING

Osaka Rosai Hospital, Osaka

105-8470

RECRUITING

Toranomon Hospital, Tokyo

1081 HV

RECRUITING

Amstedam University Medical Centers, Amsterdam

6525 GA

RECRUITING

Radboudumc, Nijmegen

08036

RECRUITING

Hospital Clínic de Barcelona, Barcelona

08208

RECRUITING

Hospital Universitari Parc Tauli, Barcelona

S016 6YD

RECRUITING

University Hospital Southampton NHS Foundation Trust, Southampton

BT12 6BA

RECRUITING

Belfast Health & Social Care Trust (BHSCT) Royal Victoria Hospital, Belfast

SE5 9RS

RECRUITING

King's College Hospital NHS Foundation Trust, London

Sponsors
All Listed Sponsors
lead

Mirum Pharmaceuticals, Inc.

INDUSTRY