A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
Public ClinicalTrials.gov record NCT05050136. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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 Biliary Cholangitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05050136
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 333 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 22, 2021 (Actual)
- Primary completion
- Jan 2027 (Estimated)
- Completion
- Dec 2028 (Estimated)
- Last update posted
- Aug 25, 2026
2021 – 2028
United States locations
- U.S. sites
- 44
- U.S. states
- 22
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern California Research Center | Coronado | California | 92218 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| UC Davis | Sacramento | California | 95817 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Yale University Digestive Diseases | New Haven | Connecticut | 06510 | — |
| Covenant Metabolic Specialists | Fort Myers | Florida | 33912 | — |
| UF Hepatology Research at CTRB | Gainesville | Florida | 32610 | — |
| UF Health Gastroenterology- Emerson | Jacksonville | Florida | 32209 | — |
| IHS Health | Kissimmee | Florida | 34741 | — |
| Schiff Center for Liver Diseases | Miami | Florida | 33136 | — |
| Advanced Research Institute, Inc | New Port Richey | Florida | 34653 | — |
| Covenant Research and Clinics, LLC | Sarasota | Florida | 34240 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Southeast Clinical Research Center | Dalton | Georgia | 30720 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Loyola University Health System - Loyola Outpatient Center | Maywood | Illinois | 60153 | — |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | — |
| Ochsner Clinic Foundation-Baton Rouge | Baton Rouge | Louisiana | 70836 | — |
| LSU Health Science Center Shreveport | Shreveport | Louisiana | 71103 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess | Boston | Massachusetts | 02215 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Jackson Liver and GI Specialists | Jackson | Mississippi | 39216 | — |
| CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan | Omaha | Nebraska | 68124 | — |
| Virtua Center for Liver Disease-Camden | Camden | New Jersey | 08103 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Science 37, Inc (Remote-homebased Telemedicine) | Morrisville | North Carolina | 27560 | — |
| Cleveland Clinic - Main Campus | Cleveland | Ohio | 44195 | — |
| Einstein Healthcare Network - Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| Methodist Le Bonheur Healthcare | Memphis | Tennessee | 38104 | — |
| Galen Medical Group, P.C | Tennessee City | Tennessee | 37343 | — |
| Amel Med LLC | Austin | Texas | 78750 | — |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| Soma Clinical Trials | Denison | Texas | 75020 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Liver Associates of Texas | Houston | Texas | 77030 | — |
| Impact Research | Waco | Texas | 76710 | — |
| University of Utah Health Care | Salt Lake City | Utah | 84132 | — |
| MedStar Health Research Institute | Fairfax | Virginia | 22031 | — |
| Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital | Newport News | Virginia | 23602 | — |
| Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23226 | — |
| Liver Institute Northwest | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 86 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05050136, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05050136 live on ClinicalTrials.gov.