A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
Start Date
9/22/2021
Completion Date
7/1/2027
Summary
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Volixibat
Placebo
Conditions
Locations
Southern California Research Center
Coronado, California 92218
United States
Cedars Sinai Medical Center
Los Angeles, California 90048
United States
University of California Los Angeles
Los Angeles, California 90095
United States
UC Davis
Sacramento, California 95817
United States
University of Colorado
Aurora, Colorado 80045
United States
Yale University Digestive Diseases
New Haven, Connecticut 06510
United States
Covenant Metabolic Specialists
Fort Myers, Florida 33912
United States
UF Hepatology Research at CTRB
Gainesville, Florida 32610
United States
UF Health Gastroenterology- Emerson
Jacksonville, Florida 32209
United States
IHS Health
Kissimmee, Florida 34741
United States
Schiff Center for Liver Diseases
Miami, Florida 33136
United States
Advanced Research Institute, Inc
New Port Richey, Florida 34653
United States
Covenant Research and Clinics, LLC
Sarasota, Florida 34240
United States
Tampa General Hospital
Tampa, Florida 33606
United States
Cleveland Clinic Florida
Weston, Florida 33331
United States
Southeast Clinical Research Center
Dalton, Georgia 30720
United States
Northwestern University
Chicago, Illinois 60611
United States
Loyola University Health System - Loyola Outpatient Center
Maywood, Illinois 60153
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United States
Ochsner Clinic Foundation-Baton Rouge
Baton Rouge, Louisiana 70836
United States
LSU Health Science Center Shreveport
Shreveport, Louisiana 71103
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Beth Israel Deaconess
Boston, Massachusetts 02215
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Jackson Liver and GI Specialists
Jackson, Mississippi 39216
United States
CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan
Omaha, Nebraska 68124
United States
Virtua Center for Liver Disease-Camden
Camden, New Jersey 08103
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
Science 37, Inc (Remote-homebased Telemedicine)
Morrisville, North Carolina 27560
United States
Cleveland Clinic - Main Campus
Cleveland, Ohio 44195
United States
Einstein Healthcare Network - Einstein Medical Center
Philadelphia, Pennsylvania 19141
United States
Methodist Le Bonheur Healthcare
Memphis, Tennessee 38104
United States
Galen Medical Group, P.C
Tennessee City, Tennessee 37343
United States
Amel Med LLC
Austin, Texas 78750
United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas 75203
United States
Soma Clinical Trials
Denison, Texas 75020
United States
Baylor College of Medicine
Houston, Texas 77030
United States
Liver Associates of Texas
Houston, Texas 77030
United States
Impact Research
Waco, Texas 76710
United States
University of Utah Health Care
Salt Lake City, Utah 84132
United States
MedStar Health Research Institute
Fairfax, Virginia 22031
United States
Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital
Newport News, Virginia 23602
United States
Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia 23226
United States
Liver Institute Northwest
Seattle, Washington 98105
United States
Hospital de Alta Complejidad En Red El Cruce
San Juan Bautista, Buenos Aires 1888
Argentina
Hospital Provincial Del Centenario
Rosario, Santa Fe Province 2000
Argentina
Glenny Corp S.A
CABA, 1430
Argentina
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
Santa Fe, 3000
Argentina
Universitair Ziekenhuis Antwerpe UZA
Antwerp, 2650
Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200
Belgium
UZ Gent
Ghent, 9000
Belgium
Centro de Pesquisa Clínica da Bahiana Saúde
Salvador, Estado de Bahia 40290-000
Brazil
Hospital Das Clínicas Da Ufg
Goiânia, Goiás 74605-050
Brazil
Centro de Pesquisas Clínicas do HC/UFMG-EBSERH
Belo Horizonte, Minas Gerais 30130-100
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul 90035903
Brazil
Hospital Universitário Clementino Fraga Filho - Secretaria de Hepatologia
Rio de Janeiro, 21941-617
Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde
Rio de Janeiro, 22775-001
Brazil
Fundação Oswaldo Ramos
São Paulo, 04038-002
Brazil
Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology
Vancouver, British Columbia V5Z 1M9
Canada
(G.I.R.I.) GI Research Institute Foundation
Vancouver, British Columbia V6Z 2K5
Canada
McMaster University Medical Center
Hamilton, Ontario L8S 4K1
Canada
University Hospital, LHSC
London, Ontario N6A5A5
Canada
Toronto General Hospital
Toronto, Ontario M5G 1Z5
Canada
McGill University Health Centre
Montreal, Quebec H4A 3J1
Canada
University of Alberta
Edmonton, T6G 2X8
Canada
CRCHUM (Centre de Recherche du Centre Hospitalier de l'Université de Montréal)
Montreal, H2X 0A9
Canada
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian 350028
China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei 430022
China
The First Hospital of Jilin University
Changchun, Jilin 130031
China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
China
Beijing Youan Hospital, Capital Medical University
Beijing, 100069
China
Beijing Friendship Hospital, Capital Medical University
Beijing, 10050
China
Sir Run Run Shaw Hospital -Zhejiang University School of Medicine
Hangzhou, 310009
China
CHU Grenoble - Hôpital MICHALLON
Grenoble, 38043
France
Hopital Claude Huriez-Digestive system disease clinic
Lille, 59037
France
CHU de NICE- Hospital L'Archet 2
Nice, 06202
France
Hospital Saint Antoine
Paris, 75012
France
Nouvel Hospital Civil
Strasbourg, 67091
France
Hospital Paul Brousse- APHP
Villejuif, 94800
France
Klinikum Chemnitz gGmbH
Chemnitz, 09116
Germany
Universitätsklinikum Frankfurt am Main
Frankfurt,
Germany
Medizinische Hochschule Hannover (MHH)
Hanover, 30625
Germany
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie
Leipzig, 04103
Germany
Otto-von-Guericke-Universität Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, 39120
Germany
University Hospital Munster
Münster, 48149
Germany
University Hospital Tübingen Medical clinic
Tübingen, 72076
Germany
St. Josefs-Hospital Wiesbaden
Wiesbaden, 65189
Germany
Hillel Yaffe Medical Center
Hadera, 3810101
Israel
Rambam Medical Center
Haifa, 3109601
Israel
Carmel Medical Center
Haifa, 3434104
Israel
Shaare Zedek Medical Center
Jerusalem, 9103102
Israel
Hadassah Medical Center - Ein Karem, Liver Institute Kiryat Hadassah POB 12000
Jerusalem, 9112001
Israel
Galilee Medical Center
Nahariya, 2210001
Israel
Rabin Medical Center
Petah Tikva, 4941492
Israel
Sheba Medical Center
Ramat Gan, 52621
Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Israel
Universita Politecnica delle Marche- Ospedali Riuniti
Ancona,
Italy
ASST Papa Giovanni XXIII
Bergamo, 24127
Italy
Fondazione Ca Granda
Milan, 20122
Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Italy
Azienda Ospedaliero Universitaria Di Modena
Modena, 41126
Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900
Italy
Azienda Ospedale-Università di Padova
Padova, 35128
Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127
Italy
Azienda Ospedaliero Universitaria Pisana (AOUP)
Pisa, 56124
Italy
Istituto Clinico Humanitas
Rozzano,
Italy
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki 856-8562
Japan
Ehime University Hospital
Ehime, 791-0295
Japan
Teine Keijinkai Hospital
Hokkaido, 006-8555
Japan
Osaka Rosai Hospital
Osaka, 591-8025
Japan
Toranomon Hospital
Tokyo, 105-8470
Japan
Amstedam University Medical Centers
Amsterdam, 1081 HV
Netherlands
Radboudumc
Nijmegen, 6525 GA
Netherlands
Erasmus medical center
Rotterdam,
Netherlands
Hospital Universitari Vall d' Hebron
Barcelona, 08035
Spain
Hospital Clínic de Barcelona
Barcelona, 08036
Spain
Hospital Universitari Parc Tauli
Barcelona, 08208
Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Spain
Hospital Universitario Virgen del Rocio
Seville, 41013
Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009
Spain
Ente Ospedaliero Cantonale
Lugano, 6900
Switzerland
University Hospital Zurich(USZ)
Zurich, 8091
Switzerland
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire S016 6YD
United Kingdom
University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters
Birmingham, West Midlands B15 2GW
United Kingdom
Belfast Health & Social Care Trust (BHSCT) Royal Victoria Hospital
Belfast, BT12 6BA
United Kingdom
Royal Free Hospital NHS Foundation Trust
London, NW3 2QZ
United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS
United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham,
United Kingdom