RECRUITING

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

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Conditions

Primary Biliary CholangitisPBCPruritusItchingCholangitisHepatobiliary disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-09-22
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05050136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study
  2. * Male or female, age ≥18 years at the screening visit
  3. * Confirmed diagnosis of PBC in line with the AASLD guidelines
  4. * UDCA and anti-pruritic medication use will be allowed if meeting additional criteria
  5. * Qualified pruritus associated with PBC as assessed by Adult ItchRO
  1. * Pruritus associated with an etiology other than PBC
  2. * Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events
  3. * Current symptomatic cholelithiasis or inflammatory gallbladder disease
  4. * History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation.
  5. * Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded
  6. * History of Liver transplantation

Contacts and Locations

Study Locations (Sites)

Southern California Research Center
Coronado, California, 92218
United States
Science 37, Inc (Remote-homebased Telemedicine)
Culver City, California, 90230
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
University of Colorado
Aurora, Colorado, 80045
United States
Covenant Metabolic Specialists
Fort Myers, Florida, 33912
United States
UF Hepatology Research at CTRB
Gainesville, Florida, 32610
United States
UF Health Gastroenterology- Emerson
Jacksonville, Florida, 32209
United States
IHS Health
Kissimmee, Florida, 34741
United States
Schiff Center for Liver Diseases
Miami, Florida, 33136
United States
Advanced Research Institute, Inc
New Port Richey, Florida, 34653
United States
Covenant Research and Clinics, LLC
Sarasota, Florida, 34240
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Southeast Clinical Research Center
Dalton, Georgia, 30720
United States
Northwestern University
Chicago, Illinois, 60611
United States
Loyola University Health System - Loyola Outpatient Center
Maywood, Illinois, 60153
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
United States
Ochsner Clinic Foundation-Baton Rouge
Baton Rouge, Louisiana, 70836
United States
LSU Health Science Center Shreveport
Shreveport, Louisiana, 71103
United States
Beth Israel Deaconess
Boston, Massachusetts, 02215
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Jackson Liver and GI Specialists
Jackson, Mississippi, 39216
United States
CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan
Omaha, Nebraska, 68124
United States
Cleveland Clinic - Main Campus
Cleveland, Ohio, 44195
United States
Einstein Healthcare Network - Einstein Medical Center
Philadelphia, Pennsylvania, 19141
United States
Methodist Le Bonheur Healthcare
Memphis, Tennessee, 38104
United States
Galen Medical Group, P.C
Tennessee, Tennessee, 37343
United States
Amel Med LLC
Austin, Texas, 78750
United States
Soma Clinical Trials
Denison, Texas, 75020
United States
Liver Associates of Texas
Houston, Texas, 77030
United States
Velocity Clinical Research
Waco, Texas, 76710
United States
University of Utah Health Care
Salt Lake City, Utah, 84132
United States
MedStar Health Research Institute
Fairfax, Virginia, 22031
United States
Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital
Newport News, Virginia, 23602
United States
Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226
United States
Liver Institute Northwest
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Mirum Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-22
Study Completion Date2025-12

Study Record Updates

Study Start Date2021-09-22
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Pruritus
  • PBC
  • Itching
  • Cholangitis
  • Primary Biliary Cholangitis
  • Hepatobiliary disorders

Additional Relevant MeSH Terms

  • Primary Biliary Cholangitis
  • PBC