NCT05050136Active, not recruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
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
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 333 (actual)
- First submitted
- 9 Sept 2021
- Start date
- 22 Sept 2021
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Mirum Pharmaceuticals, Inc.
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT05050136
- EU CT number
- 2023-504660-41-00
- EudraCT number
- 2021-001389-39
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 333
- From 22 Sept 2021 to the primary completion date, 31 Jan 2027
- 130 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Pruritus associated with an etiology other than PBC
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (130)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Glenny Corp. S.A Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Hospital Provincial del Centenario Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Hospital de Alta Complejidad en Red 'El Cruce' Coordinator of this site? Confirm its status | San Juan Bautista | Argentina | Unknown status |
| Clínica de Nefrología, Urología y Enfermedades Cardiovasculares Coordinator of this site? Confirm its status | Santa Fe | Argentina | Unknown status |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Active, not recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Active, not recruiting |
| Centro de Pesquisas Clínicas do HC/UFMG-EBSERH Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Hospital Das Clínicas Da Ufg Coordinator of this site? Confirm its status | Goiânia | Brazil | Unknown status |
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto de Educacao Pesquisa e Gestao em Saude Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Hospital Universitário Clementino Fraga Filho - Secretaria de Hepatologia Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Centro de Pesquisa Clínica da Bahiana Saúde Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Fundação Oswaldo Ramos Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| McMaster University Medical Center Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| University Hospital (LHSC) Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CRCHUM (Centre de Recherche du Centre Hospitalier de l'Université de Montréal) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| (G.I.R.I.) GI Research Institute Foundation Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Ente Ospedaliero Cantonale Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
| University Hospital Zurich (USZ) Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Beijing YouAn Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Mengchao Hepatobiliary Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Klinikum Chemnitz gGmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Active, not recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Active, not recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein Coordinator of this site? Confirm its status | Kiel | Germany | Active, not recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Active, not recruiting |
| Otto Von Guericke Universitaet Magdeburg Coordinator of this site? Confirm its status | Magdeburg | Germany | Active, not recruiting |
| Westfaelische Wilhelms-Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Active, not recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| St. Josefs-Hospital Wiesbaden GmbH Coordinator of this site? Confirm its status | Wiesbaden | Germany | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Active, not recruiting |
| Hopital Huriez Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Active, not recruiting |
| Hopital Saint Antoine Coordinator of this site? Confirm its status | Paris Cedex 12 | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Active, not recruiting |
| Hopital Paul Brousse Coordinator of this site? Confirm its status | Villejuif Cedex | France | Active, not recruiting |
| Belfast Health & Social Care Trust (BHSCT) Royal Victoria Hospital Coordinator of this site? Confirm its status | Belfast | United Kingdom | Unknown status |
| University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| King's College Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Free Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Freeman Hospital Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Hillel Yaffe Medical Center Coordinator of this site? Confirm its status | Hadera | Israel | Unknown status |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Medical Center - Ein Karem, Liver Institute Kiryat Hadassah POB 12000 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Galilee Medical Center Coordinator of this site? Confirm its status | Nahariya | Israel | Unknown status |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| The Tel Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Active, not recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Active, not recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Active, not recruiting |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Active, not recruiting |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Active, not recruiting |
| Ehime University Hospital Coordinator of this site? Confirm its status | Ehime | Japan | Unknown status |
| Teine Keijinkai Hospital Coordinator of this site? Confirm its status | Hokkaido | Japan | Unknown status |
| National Hospital Organization Nagasaki Medical Center Coordinator of this site? Confirm its status | Ōmura | Japan | Unknown status |
| Osaka Rosai Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Toranomon Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Stichting Radboud Universitair Medisch Centrum Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Active, not recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Amel Med LLC Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Ochsner Clinic Foundation-Baton Rouge Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Beth Israel Deaconess Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Virtua Center for Liver Disease-Camden Coordinator of this site? Confirm its status | Camden | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cleveland Clinic - Main Campus Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Southern California Research Center Coordinator of this site? Confirm its status | Coronado | United States | Unknown status |
| The Liver Institute at Methodist Dallas Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Southeast Clinical Research Center Coordinator of this site? Confirm its status | Dalton | United States | Unknown status |
| Soma Clinical Trials Coordinator of this site? Confirm its status | Denison | United States | Unknown status |
| MedStar Health Research Institute Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Covenant Metabolic Specialists Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| UF Hepatology Research at CTRB Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Liver Associates of Texas Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Iowa Hospitals & Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Jackson Liver and GI Specialists Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| UF Health Gastroenterology- Emerson Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| IHS Health Coordinator of this site? Confirm its status | Kissimmee | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Loyola University Health System - Loyola Outpatient Center Coordinator of this site? Confirm its status | Maywood | United States | Unknown status |
| Methodist Le Bonheur Healthcare Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Schiff Center for Liver Diseases Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Science 37, Inc (Remote-homebased Telemedicine) Coordinator of this site? Confirm its status | Morrisville | United States | Unknown status |
| Yale University Digestive Diseases Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital Coordinator of this site? Confirm its status | Newport News | United States | Unknown status |
| Advanced Research Institute, Inc. Coordinator of this site? Confirm its status | New Port Richey | United States | Unknown status |
| CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Einstein Healthcare Network - Einstein Medical Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| UC Davis Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| University of Utah Health Care Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Covenant Research and Clinics, LLC Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Liver Institute Northwest Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| LSU Health Science Center Shreveport Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Galen Medical Group, P.C Coordinator of this site? Confirm its status | Tennessee City | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Impact Research Coordinator of this site? Confirm its status | Waco | United States | Unknown status |
| Cleveland Clinic Florida Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.