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ACTIVE NOT RECRUITING
NCT04663308
PHASE2

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

Sponsor: Mirum Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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 Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.

Official title: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Sclerosing Cholangitis

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

182

Start Date

2020-12-18

Completion Date

2027-04

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DRUG

Volixibat

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

DRUG

Placebo

Capsules matched to study drug minus active substance

Locations (103)

Southern California Research Center

Coronado, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

University of California, Davis

Sacramento, California, United States

California Pacific Medical Center Research Institute

San Francisco, California, United States

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Florida Research Institute

Lakewood Rch, Florida, United States

University of Miami - Schiff Center for Liver Diseases

Miami, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Southern Therapy and Advanced Research LLC

Jackson, Mississippi, United States

Northwell Health

Manhasset, New York, United States

New York University Langone Health

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

Columbia University Medical Center - Presbyterian Hospital and Vanderbilt Clinic

New York, New York, United States

University of Rochester Medical Center - Strong Memorial Hospital

Rochester, New York, United States

Duke Health - Duke University Medical Center

Durham, North Carolina, United States

Science 37, Inc (Remote-homebased Telemedicine)

Morrisville, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Einstein Healthcare Network - Einstein Medical Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Galen Medical Group

Hixson, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

The Liver Institute At Methodist Dallas Medical Center

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Liver Associates of Texas

Houston, Texas, United States

University of Utah Health Care

Salt Lake City, Utah, United States

Bon Secours Liver Institution of Hampton Roads Mary Immaculate Hospital Office

Newport News, Virginia, United States

Richmond Community Hospital LLC

Richmond, Virginia, United States

University of Washington - Harborview Medical Center

Seattle, Washington, United States

Liver Institute Northwest

Seattle, Washington, United States

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Glenny Corp S.A.

Ciudad Autónoma Buenos Aires, Argentina

Hospital El Cruce

San Juan Bautista, Argentina

Royal Adelaide Hospital

Adelaide, Australia

Northern Health

Epping, Australia

Liverpool Hospital

Liverpool, Australia

Austin Health

Melbourne, Australia

University of the Sunshine Coast

Sippy Downs, Australia

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Antwerpen (UZA)

Ghent, Belgium

University Hospital Ghent

Ghent, Belgium

Hospital das Clinicas da UFMG

Belo Horizonte, Brazil

Hospital Das Clinicas Da Ufg

Goiânia, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Brazil

Escola Bahiana de Medicina e Saude Publica

Salvador, Brazil

Hospital do Rim e Hipertensao

São Paulo, Brazil

University of Alberta

Edmonton, Alberta, Canada

McMaster University Hospital

Hamilton, Ontario, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

University of Calgary

Calgary, Canada

London Health Sciences Centre University Hospital

London, Canada

McGill University Health Centre - Royal Victoria Hospital

Montreal, Canada

Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes)

Grenoble, France

Centre Hospitalier Universitaire De Lille

Lille, France

APHP-Hôpital Saint Antoine

Paris, France

CHU Bordeaux - Haut Lévêque

Pessac, France

Hannover Medical School

Hanover, Lower Saxony, Germany

Universitaetsklinikum Bonn

Bonn, Nordrhine-Westphalia, Germany

Charité Universtitätsmedizin - Campus Virchow-Klinikum

Berlin, Germany

Universitaetsklinikum Erlangen

Erlangen, Germany

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Germany

Universitatsklinikum Leipzig

Leipzig, Germany

Otto-von-Guericke-Universitat Magdeburg

Magdeburg, Germany

University Hospital Tubingen Medical Clinic

Tübingen, Germany

St. Josefs-Hospital Wiesbaden

Wiesbaden, Germany

Hillel Yaffe Medical Center

Hadera, Israel

Rambam Medical Center

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah Medical Center - Ein Karem

Jerusalem, Israel

Galilee Medical Center

Nahariya, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S. Orsola-Malpighi

Bologna, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

A.O.U. Federico II

Naples, Italy

Azienda Ospedale Universita Padova

Padova, Italy

Amsterdam UMC - VU Medisch Centrum (VUmc)

Amsterdam, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Radboud University Medical Centre (MC)

Nijmegen, Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands

Hospital Clinic Barcelona

Barcelona, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

University Hospital Zurich

Zurich, Switzerland

Royal Free Hospital

London, Hampstead, United Kingdom

John Radcliffe Hospital

Oxford, Headington, United Kingdom

Royal Victoria Hospital

Belfast, United Kingdom

University Hospitals Birmingham NHS Foundation Trust - Wellcome Trust Birmingham Clinical Research Facility

Birmingham, United Kingdom

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

Cambridge, United Kingdom

Lothian NHS Board

Edinburgh, United Kingdom

St James' University Hospital Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

Nottingham University Hospital NHS Trust

Nottingham, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom