A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
Condition(s) studied
Investigational drug(s) / intervention(s)
Volixibat: Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.
Placebo: Capsules matched to study drug minus active substance
Study 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 Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.
Eligibility
Primary outcome measure(s)
- Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire — Baseline through to Week 28
The Adult ItchRO is an 11-point NRS measurement of itch severity ranging from 0=no itch to 10=worst possible itch.
Trial sites (103)
| Facility | City | Region | Status |
|---|---|---|---|
| Southern California Research Center | Coronado | California | |
| Cedars Sinai Medical Center | Los Angeles | California | |
| University of California, Davis | Sacramento | California | |
| California Pacific Medical Center Research Institute | San Francisco | California | |
| University of Colorado - Anschutz Medical Campus | Aurora | Colorado | |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | |
| Florida Research Institute | Lakewood Rch | Florida | |
| University of Miami - Schiff Center for Liver Diseases | Miami | Florida | |
| Tampa General Hospital | Tampa | Florida | |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | |
| Henry Ford Hospital | Detroit | Michigan | |
| Mayo Clinic | Rochester | Minnesota | |
| Southern Therapy and Advanced Research LLC | Jackson | Mississippi | |
| Northwell Health | Manhasset | New York | |
| New York University Langone Health | New York | New York | |
| Weill Cornell Medical College | New York | New York | |
| Columbia University Medical Center - Presbyterian Hospital and Vanderbilt Clinic | New York | New York | |
| University of Rochester Medical Center - Strong Memorial Hospital | Rochester | New York | |
| Duke Health - Duke University Medical Center | Durham | North Carolina | |
| Science 37, Inc (Remote-homebased Telemedicine) | Morrisville | North Carolina | |
| Cleveland Clinic | Cleveland | Ohio | |
| Einstein Healthcare Network - Einstein Medical Center | Philadelphia | Pennsylvania | |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | |
| Galen Medical Group | Hixson | Tennessee | |
| Vanderbilt University Medical Center | Nashville | Tennessee | |
| The Liver Institute At Methodist Dallas Medical Center | Dallas | Texas | |
| University of Texas Southwestern Medical Center | Dallas | Texas | |
| Houston Methodist Hospital | Houston | Texas | |
| Liver Associates of Texas | Houston | Texas | |
| University of Utah Health Care | Salt Lake City | Utah | |
| Bon Secours Liver Institution of Hampton Roads Mary Immaculate Hospital Office | Newport News | Virginia | |
| Richmond Community Hospital LLC | Richmond | Virginia | |
| University of Washington - Harborview Medical Center | Seattle | Washington | |
| Liver Institute Northwest | Seattle | Washington | |
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | |
| Glenny Corp S.A. | Ciudad Autónoma Buenos Aires | Argentina | |
| Hospital El Cruce | San Juan Bautista | Argentina | |
| Royal Adelaide Hospital | Adelaide | Australia | |
| Northern Health | Epping | Australia | |
| Liverpool Hospital | Liverpool | Australia |
+ 63 more sites — see the full list on the official registry below.
More Mirum Pharmaceuticals, Inc. trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04663308 on ClinicalTrials.gov ↗ ← All trials in France