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 Biliary Cholangitis
Who is this study for? Patients with cholestatic pruritus associated with primary biliary cholangitis
What treatments are being studied? Volixibat
Status: Recruiting
Location: See all (105) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Southern California Research Center
TERMINATED
Coronado
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Colorado
University of Colorado
RECRUITING
Aurora
Florida
Covenant Metabolic Specialists
RECRUITING
Fort Myers
UF Hepatology Research at CTRB
RECRUITING
Gainesville
UF Health Gastroenterology- Emerson
RECRUITING
Jacksonville
IHS Health
TERMINATED
Kissimmee
Schiff Center for Liver Diseases
RECRUITING
Miami
Advanced Research Institute, Inc
RECRUITING
New Port Richey
Covenant Research and Clinics, LLC
RECRUITING
Sarasota
Tampa General Hospital
RECRUITING
Tampa
Georgia
Southeast Clinical Research Center
RECRUITING
Dalton
Iowa
University of Iowa Hospitals & Clinics
RECRUITING
Iowa City
Illinois
Northwestern University
RECRUITING
Chicago
Loyola University Health System - Loyola Outpatient Center
RECRUITING
Maywood
Louisiana
Ochsner Clinic Foundation-Baton Rouge
RECRUITING
Baton Rouge
LSU Health Science Center Shreveport
RECRUITING
Shreveport
Massachusetts
Beth Israel Deaconess
RECRUITING
Boston
Minnesota
Mayo Clinic
RECRUITING
Rochester
Mississippi
Jackson Liver and GI Specialists
TERMINATED
Jackson
North Carolina
Science 37, Inc (Remote-homebased Telemedicine)
RECRUITING
Morrisville
Nebraska
CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan
RECRUITING
Omaha
Ohio
Cleveland Clinic - Main Campus
RECRUITING
Cleveland
Pennsylvania
Einstein Healthcare Network - Einstein Medical Center
RECRUITING
Philadelphia
Tennessee
Methodist Le Bonheur Healthcare
TERMINATED
Memphis
Galen Medical Group, P.C
RECRUITING
Tennessee City
Texas
Amel Med LLC
RECRUITING
Austin
Soma Clinical Trials
RECRUITING
Denison
Baylor College of Medicine
RECRUITING
Houston
Liver Associates of Texas
RECRUITING
Houston
Velocity Clinical Research
RECRUITING
Waco
Utah
University of Utah Health Care
RECRUITING
Salt Lake City
Virginia
MedStar Health Research Institute
RECRUITING
Fairfax
Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital
RECRUITING
Newport News
Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond
RECRUITING
Richmond
Washington
Liver Institute Northwest
RECRUITING
Seattle
Other Locations
Argentina
Glenny Corp S.A
RECRUITING
Caba
Hospital Provincial Del Centenario
RECRUITING
Rosario
Hospital de Alta Complejidad En Red El Cruce
RECRUITING
San Juan Bautista
Belgium
Universitair Ziekenhuis Antwerpe UZA
RECRUITING
Antwerp
Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
UZ Gent
RECRUITING
Ghent
Brazil
Centro de Pesquisas Clínicas do HC/UFMG-EBSERH
RECRUITING
Belo Horizonte
Hospital Das Clínicas Da Ufg
RECRUITING
Goiânia
Hospital de Clínicas de Porto Alegre
RECRUITING
Porto Alegre
Centro de Pesquisa Clínica da Bahiana Saúde
RECRUITING
Salvador
Fundação Oswaldo Ramos
RECRUITING
São Paulo
Canada
University of Alberta
RECRUITING
Edmonton
McMaster University Medical Center
RECRUITING
Hamilton
University Hospital, LHSC
RECRUITING
London
McGill University Health Centre
RECRUITING
Montreal
Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology
RECRUITING
Vancouver
China
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Youan Hospital, Capital Medical University
RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
Mengchao Hepatobiliary Hospital of Fujian Medical University
RECRUITING
Fuzhou
Sir Run Run Shaw Hospital -Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
France
CHU Grenoble - Hôpital MICHALLON
RECRUITING
Grenoble
Hopital Claude Huriez-Digestive system disease clinic
RECRUITING
Lille
CHU de NICE- Hospital L'Archet 2
RECRUITING
Nice
Hospital Saint Antoine
RECRUITING
Paris
Nouvel Hospital Civil
RECRUITING
Strasbourg
Hospital Paul Brousse- APHP
RECRUITING
Villejuif
Germany
Klinikum Chemnitz gGmbH
RECRUITING
Chemnitz
Universitätsklinikum Frankfurt am Main
RECRUITING
Frankfurt
Medizinische Hochschule Hannover (MHH)
RECRUITING
Hanover
Universitätsklinikum Schleswig-Holstein
RECRUITING
Kiel
University Hospital Munster
RECRUITING
Münster
University Hospital Tübingen Medical clinic
RECRUITING
Tübingen
St. Josefs-Hospital Wiesbaden
RECRUITING
Wiesbaden
Israel
Hillel Yaffe Medical Center
RECRUITING
Hadera
Carmel Medical Center
RECRUITING
Haifa
Rambam Medical Center
RECRUITING
Haifa
Hadassah Medical Center - Ein Karem, Liver Institute Kiryat Hadassah POB 12000
RECRUITING
Jerusalem
Shaare Zedek Medical Center
TERMINATED
Jerusalem
Galilee Medical Center
RECRUITING
Nahariya
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
The Tel Aviv Sourasky Medical Center
TERMINATED
Tel Aviv
Italy
Universita Politecnica delle Marche- Ospedali Riuniti
RECRUITING
Ancona
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Fondazione Ca Granda
RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING
Monza
Azienda Ospedale-Università di Padova
RECRUITING
Padua
Azienda Ospedaliero Universitaria Pisana (AOUP)
RECRUITING
Pisa
Istituto Clinico Humanitas
RECRUITING
Rozzano
Japan
Ehime University Hospital
RECRUITING
Ehime
Teine Keijinkai Hospital
RECRUITING
Hokkaido
National Hospital Organization Nagasaki Medical Center
RECRUITING
Ōmura
Osaka Rosai Hospital
RECRUITING
Osaka
Toranomon Hospital
RECRUITING
Tokyo
Netherlands
Amstedam University Medical Centers
RECRUITING
Amsterdam
Radboudumc
RECRUITING
Nijmegen
Erasmus medical center
RECRUITING
Rotterdam
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Parc Tauli
RECRUITING
Barcelona
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Switzerland
University Hospital Zurich(USZ)
RECRUITING
Zurich
United Kingdom
Belfast Health & Social Care Trust (BHSCT) Royal Victoria Hospital
RECRUITING
Belfast
King's College Hospital NHS Foundation Trust
RECRUITING
London
Nottingham University Hospitals NHS Trust
RECRUITING
Nottingham
University Hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
Time Frame
Start Date: 2021-09-22
Estimated Completion Date: 2027-07
Participants
Target number of participants: 260
Treatments
Experimental: Part 1 Arm 1: Volixibat 20mg
Participants randomized to this arm will receive volixibat 20mg twice daily.
Experimental: Part 1 Arm 2: Volixibat 80mg
Participants randomized to this arm will receive volixibat 80mg twice daily.
Placebo_comparator: Part 1 Arm 3: Placebo
Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
Experimental: Part 2 Arm 1: Volixibat Selected Dose 20mg
Participants randomized to this arm will receive volixibat 20mg twice daily.
Placebo_comparator: Part 2 Arm 2: Placebo
Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
Related Therapeutic Areas
Sponsors
Leads: Mirum Pharmaceuticals, Inc.