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Active, not recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT04663308

Public ClinicalTrials.gov record NCT04663308. 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.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 6:01 AM EDT

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

Study identification

NCT ID
NCT04663308
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Enrollment
182 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
12 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
Dec 18, 2020 (Actual)
Primary completion
Feb 20, 2026 (Actual)
Completion
Mar 2028 (Estimated)
Last update posted
Oct 19, 2026

2020 – 2028

United States locations

U.S. sites
34
U.S. states
17
U.S. cities
29
Facility City State ZIP Site status
Southern California Research Center Coronado California 92118 —
Cedars Sinai Medical Center Los Angeles California 90048 —
University of California, Davis Sacramento California 95817 —
California Pacific Medical Center Research Institute San Francisco California 94109 —
University of Colorado - Anschutz Medical Campus Aurora Colorado 80045 —
MedStar Georgetown University Hospital Washington D.C. District of Columbia 20007 —
Florida Research Institute Lakewood Rch Florida 34211 —
University of Miami - Schiff Center for Liver Diseases Miami Florida 33136 —
Tampa General Hospital Tampa Florida 33606 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Henry Ford Hospital Detroit Michigan 48202 —
Mayo Clinic Rochester Minnesota 55905 —
Southern Therapy and Advanced Research LLC Jackson Mississippi 39216 —
Northwell Health Manhasset New York 11030 —
New York University Langone Health New York New York 10016 —
Weill Cornell Medical College New York New York 10021 —
Columbia University Medical Center - Presbyterian Hospital and Vanderbilt Clinic New York New York 10032 —
University of Rochester Medical Center - Strong Memorial Hospital Rochester New York 14642 —
Duke Health - Duke University Medical Center Durham North Carolina 27710 —
Science 37, Inc (Remote-homebased Telemedicine) Morrisville North Carolina 27560 —
Cleveland Clinic Cleveland Ohio 44195 —
Einstein Healthcare Network - Einstein Medical Center Philadelphia Pennsylvania 19141 —
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15213 —
Galen Medical Group Hixson Tennessee 37343 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
The Liver Institute At Methodist Dallas Medical Center Dallas Texas 75203 —
University of Texas Southwestern Medical Center Dallas Texas 75390 —
Houston Methodist Hospital Houston Texas 77030 —
Liver Associates of Texas Houston Texas 77030 —
University of Utah Health Care Salt Lake City Utah 84132 —
Bon Secours Liver Institution of Hampton Roads Mary Immaculate Hospital Office Newport News Virginia 23603 —
Richmond Community Hospital LLC Richmond Virginia 23226 —
University of Washington - Harborview Medical Center Seattle Washington 98104 —
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 69 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04663308, 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 Oct 19, 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 NCT04663308 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →