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NCT05050136PHASE2Recruiting

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

Mirum Pharmaceuticals, Inc.

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

Inclusion Criteria: * Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study * Male or female, age ≥18 years at the screening visit * Confirmed diagnosis of PBC in line with the AASLD guidelines * UDCA, anti-pruritic medication and PPAR agonist use will be allowed if meeting additional criteria * Qualified pruritus associated with PBC as assessed by Adult ItchRO Exclusion Criteria: * Pruritus associated with an etiology other than PBC * Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events * Current symptomatic cholelithiasis or inflammatory gallbladder disease * History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation. * Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded * History of Liver transplantation

Interventions

DRUG

Volixibat

DRUG

Placebo

Interested in This Trial?

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Conditions

Primary Biliary CholangitisPBC

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