Actively Recruiting
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
Led by Mirum Pharmaceuticals, Inc. · Updated on 2026-05-14
260
Participants Needed
130
Research Sites
301 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed informed consent and comply with all study visits and requirements
- Male or female aged 18 years or older at screening
- Confirmed diagnosis of Primary Biliary Cholangitis (PBC) following AASLD guidelines
- Use of UDCA, anti-pruritic medication, and PPAR agonists allowed if meeting additional criteria
- Qualified pruritus associated with PBC as assessed by Adult ItchRO
You will not qualify if you...
- Pruritus caused by conditions other than Primary Biliary Cholangitis
- Evidence or suspicion of decompensated cirrhosis or history of decompensation events
- Current symptomatic gallbladder disease or cholelithiasis
- History of small bowel surgery or resection affecting the terminal ileum
- Evidence, history, or suspicion of other liver diseases (PBC patients with autoimmune hepatitis are allowed)
- History of liver transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 130 locations
1
Southern California Research Center
Coronado, California, United States, 92218
Terminated
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
4
UC Davis
Sacramento, California, United States, 95817
Actively Recruiting
5
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Yale University Digestive Diseases
New Haven, Connecticut, United States, 06510
Actively Recruiting
7
Covenant Metabolic Specialists
Fort Myers, Florida, United States, 33912
Terminated
8
UF Hepatology Research at CTRB
Gainesville, Florida, United States, 32610
Actively Recruiting
9
UF Health Gastroenterology- Emerson
Jacksonville, Florida, United States, 32209
Terminated
10
IHS Health
Kissimmee, Florida, United States, 34741
Terminated
11
Schiff Center for Liver Diseases
Miami, Florida, United States, 33136
Terminated
12
Advanced Research Institute, Inc
New Port Richey, Florida, United States, 34653
Actively Recruiting
13
Covenant Research and Clinics, LLC
Sarasota, Florida, United States, 34240
Terminated
14
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
15
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Actively Recruiting
16
Southeast Clinical Research Center
Dalton, Georgia, United States, 30720
Terminated
17
Northwestern University
Chicago, Illinois, United States, 60611
Terminated
18
Loyola University Health System - Loyola Outpatient Center
Maywood, Illinois, United States, 60153
Actively Recruiting
19
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
20
Ochsner Clinic Foundation-Baton Rouge
Baton Rouge, Louisiana, United States, 70836
Actively Recruiting
21
LSU Health Science Center Shreveport
Shreveport, Louisiana, United States, 71103
Actively Recruiting
22
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
23
Beth Israel Deaconess
Boston, Massachusetts, United States, 02215
Actively Recruiting
24
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
25
Jackson Liver and GI Specialists
Jackson, Mississippi, United States, 39216
Terminated
26
CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan
Omaha, Nebraska, United States, 68124
Actively Recruiting
27
Virtua Center for Liver Disease-Camden
Camden, New Jersey, United States, 08103
Actively Recruiting
28
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
29
Science 37, Inc (Remote-homebased Telemedicine)
Morrisville, North Carolina, United States, 27560
Actively Recruiting
30
Cleveland Clinic - Main Campus
Cleveland, Ohio, United States, 44195
Actively Recruiting
31
Einstein Healthcare Network - Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Actively Recruiting
32
Methodist Le Bonheur Healthcare
Memphis, Tennessee, United States, 38104
Terminated
33
Galen Medical Group, P.C
Tennessee City, Tennessee, United States, 37343
Actively Recruiting
34
Amel Med LLC
Austin, Texas, United States, 78750
Terminated
35
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Actively Recruiting
36
Soma Clinical Trials
Denison, Texas, United States, 75020
Terminated
37
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
38
Liver Associates of Texas
Houston, Texas, United States, 77030
Actively Recruiting
39
Impact Research
Waco, Texas, United States, 76710
Terminated
40
University of Utah Health Care
Salt Lake City, Utah, United States, 84132
Actively Recruiting
41
MedStar Health Research Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
42
Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital
Newport News, Virginia, United States, 23602
Terminated
43
Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia, United States, 23226
Actively Recruiting
44
Liver Institute Northwest
Seattle, Washington, United States, 98105
Actively Recruiting
45
Hospital de Alta Complejidad En Red El Cruce
San Juan Bautista, Buenos Aires, Argentina, 1888
Actively Recruiting
46
Hospital Provincial Del Centenario
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
47
Glenny Corp S.A
CABA, Argentina, 1430
Actively Recruiting
48
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
Santa Fe, Argentina, 3000
Actively Recruiting
49
Universitair Ziekenhuis Antwerpe UZA
Antwerp, Belgium, 2650
Actively Recruiting
50
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
51
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
52
Centro de Pesquisa Clínica da Bahiana Saúde
Salvador, Estado de Bahia, Brazil, 40290-000
Actively Recruiting
53
Hospital Das Clínicas Da Ufg
Goiânia, Goiás, Brazil, 74605-050
Actively Recruiting
54
Centro de Pesquisas Clínicas do HC/UFMG-EBSERH
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Actively Recruiting
55
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035903
Actively Recruiting
56
Hospital Universitário Clementino Fraga Filho - Secretaria de Hepatologia
Rio de Janeiro, Brazil, 21941-617
Actively Recruiting
57
Instituto de Educação, Pesquisa e Gestão em Saúde
Rio de Janeiro, Brazil, 22775-001
Actively Recruiting
58
Fundação Oswaldo Ramos
São Paulo, Brazil, 04038-002
Actively Recruiting
59
Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
60
(G.I.R.I.) GI Research Institute Foundation
Vancouver, British Columbia, Canada, V6Z 2K5
Actively Recruiting
61
McMaster University Medical Center
Hamilton, Ontario, Canada, L8S 4K1
Actively Recruiting
62
University Hospital, LHSC
London, Ontario, Canada, N6A5A5
Actively Recruiting
63
Toronto General Hospital
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
64
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
65
University of Alberta
Edmonton, Canada, T6G 2X8
Actively Recruiting
66
CRCHUM (Centre de Recherche du Centre Hospitalier de l'Université de Montréal)
Montreal, Canada, H2X 0A9
Actively Recruiting
67
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350028
Actively Recruiting
68
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
69
The First Hospital of Jilin University
Changchun, Jilin, China, 130031
Actively Recruiting
70
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
71
Beijing Youan Hospital, Capital Medical University
Beijing, China, 100069
Actively Recruiting
72
Beijing Friendship Hospital, Capital Medical University
Beijing, China, 10050
Actively Recruiting
73
Sir Run Run Shaw Hospital -Zhejiang University School of Medicine
Hangzhou, China, 310009
Actively Recruiting
74
CHU Grenoble - Hôpital MICHALLON
Grenoble, France, 38043
Actively Recruiting
75
Hopital Claude Huriez-Digestive system disease clinic
Lille, France, 59037
Actively Recruiting
76
CHU de NICE- Hospital L'Archet 2
Nice, France, 06202
Actively Recruiting
77
Hospital Saint Antoine
Paris, France, 75012
Actively Recruiting
78
Nouvel Hospital Civil
Strasbourg, France, 67091
Actively Recruiting
79
Hospital Paul Brousse- APHP
Villejuif, France, 94800
Actively Recruiting
80
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09116
Actively Recruiting
81
Universitätsklinikum Frankfurt am Main
Frankfurt, Germany
Actively Recruiting
82
Medizinische Hochschule Hannover (MHH)
Hanover, Germany, 30625
Actively Recruiting
83
Universitätsklinikum Schleswig-Holstein
Kiel, Germany, 24105
Actively Recruiting
84
Universitätsklinikum Leipzig, Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie
Leipzig, Germany, 04103
Actively Recruiting
85
Otto-von-Guericke-Universität Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, Germany, 39120
Actively Recruiting
86
University Hospital Munster
Münster, Germany, 48149
Actively Recruiting
87
University Hospital Tübingen Medical clinic
Tübingen, Germany, 72076
Actively Recruiting
88
St. Josefs-Hospital Wiesbaden
Wiesbaden, Germany, 65189
Active, Not Recruiting
89
Hillel Yaffe Medical Center
Hadera, Israel, 3810101
Terminated
90
Rambam Medical Center
Haifa, Israel, 3109601
Actively Recruiting
91
Carmel Medical Center
Haifa, Israel, 3434104
Actively Recruiting
92
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Terminated
93
Hadassah Medical Center - Ein Karem, Liver Institute Kiryat Hadassah POB 12000
Jerusalem, Israel, 9112001
Actively Recruiting
94
Galilee Medical Center
Nahariya, Israel, 2210001
Actively Recruiting
95
Rabin Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
96
Sheba Medical Center
Ramat Gan, Israel, 52621
Actively Recruiting
97
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Terminated
98
Universita Politecnica delle Marche- Ospedali Riuniti
Ancona, Italy
Actively Recruiting
99
ASST Papa Giovanni XXIII
Bergamo, Italy, 24127
Actively Recruiting
100
Fondazione Ca Granda
Milan, Italy, 20122
Terminated
101
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
102
Azienda Ospedaliero Universitaria Di Modena
Modena, Italy, 41126
Actively Recruiting
103
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy, 20900
Actively Recruiting
104
Azienda Ospedale-Università di Padova
Padova, Italy, 35128
Actively Recruiting
105
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127
Actively Recruiting
106
Azienda Ospedaliero Universitaria Pisana (AOUP)
Pisa, Italy, 56124
Actively Recruiting
107
Istituto Clinico Humanitas
Rozzano, Italy
Actively Recruiting
108
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, Japan, 856-8562
Actively Recruiting
109
Ehime University Hospital
Ehime, Japan, 791-0295
Actively Recruiting
110
Teine Keijinkai Hospital
Hokkaido, Japan, 006-8555
Actively Recruiting
111
Osaka Rosai Hospital
Osaka, Japan, 591-8025
Actively Recruiting
112
Toranomon Hospital
Tokyo, Japan, 105-8470
Actively Recruiting
113
Amstedam University Medical Centers
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
114
Radboudumc
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
115
Erasmus medical center
Rotterdam, Netherlands
Actively Recruiting
116
Hospital Universitari Vall d' Hebron
Barcelona, Spain, 08035
Actively Recruiting
117
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
118
Hospital Universitari Parc Tauli
Barcelona, Spain, 08208
Actively Recruiting
119
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
120
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
121
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
122
Ente Ospedaliero Cantonale
Lugano, Switzerland, 6900
Actively Recruiting
123
University Hospital Zurich(USZ)
Zurich, Switzerland, 8091
Actively Recruiting
124
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, S016 6YD
Actively Recruiting
125
University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters
Birmingham, West Midlands, United Kingdom, B15 2GW
Actively Recruiting
126
Belfast Health & Social Care Trust (BHSCT) Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA
Actively Recruiting
127
Royal Free Hospital NHS Foundation Trust
London, United Kingdom, NW3 2QZ
Actively Recruiting
128
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Actively Recruiting
129
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
130
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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