ACTIVE_NOT_RECRUITING

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

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Conditions

Primary Sclerosing CholangitisPruritusPSCItchItchingCholestasis

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

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

Quick Facts

Study Start:2020-12-18
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04663308

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:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provide freely signed informed consent and assent (as applicable) and be willing to comply with all study visits and requirements through end of study, including the follow-up period.
  2. 2. Subjects aged ≥12 years for eligible regions; otherwise ≥18 years
  3. 3. Confirmed diagnosis of large duct or small duct PSC based on American Association for the Study of Liver Disease (AASLD) guidelines.
  4. 4. Pruritus associated with PSC as assessed by Adult ItchRO.
  5. 5. Ursodeoxycholic acid (UDCA) and anti-pruritic medication use will be allowed if meeting additional criteria.
  6. 6. Concomitant Inflammatory Bowel Disease (IBD) is allowed if meeting additional criteria.
  1. 1. Pruritus associated with an etiology other than PSC
  2. 2. Evidence or clinical suspicion of decompensated cirrhosis, or a history of decompensation events
  3. 3. History of ileostomy or small bowel surgery/resection or other surgeries that may have disrupted the enterohepatic circulation
  4. 4. Evidence, history, or suspicion of other liver disease; PSC patients with AIH are not excluded.
  5. 5. Bile duct stent or percutaneous bile duct drain placement, or balloon dilatation procedure of a stricture within 12 weeks of Screening
  6. 6. Exceeding pre-defined biochemical values for alanine aminotransferase/aspartate aminotransferase (ALT/AST), estimated glomerular filtration rate (eGFR),serum creatinine (sCr), platelet count, international normalized ratio (INR) and total bilirubin
  7. 7. History of liver transplantation

Contacts and Locations

Study Locations (Sites)

Southern California Research Center
Coronado, California, 92118
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
University of California, Davis
Sacramento, California, 95817
United States
California Pacific Medical Center Research Institute
San Francisco, California, 94109
United States
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
United States
Florida Research Institute
Lakewood Rch, Florida, 34211
United States
University of Miami - Schiff Center for Liver Diseases
Miami, Florida, 33136
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Southern Therapy and Advanced Research LLC
Jackson, Mississippi, 39216
United States
Northwell Health
Manhasset, New York, 11030
United States
New York University Langone Health
New York, New York, 10016
United States
Weill Cornell Medical College
New York, New York, 10021
United States
Columbia University Medical Center - Presbyterian Hospital and Vanderbilt Clinic
New York, New York, 10032
United States
University of Rochester Medical Center - Strong Memorial Hospital
Rochester, New York, 14642
United States
Duke Health - Duke University Medical Center
Durham, North Carolina, 27710
United States
Science 37, Inc (Remote-homebased Telemedicine)
Morrisville, North Carolina, 27560
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Einstein Healthcare Network - Einstein Medical Center
Philadelphia, Pennsylvania, 19141
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
Galen Medical Group
Hixson, Tennessee, 37343
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
The Liver Institute At Methodist Dallas Medical Center
Dallas, Texas, 75203
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Liver Associates of Texas
Houston, Texas, 77030
United States
University of Utah Health Care
Salt Lake City, Utah, 84132
United States
Bon Secours Liver Institution of Hampton Roads Mary Immaculate Hospital Office
Newport News, Virginia, 23603
United States
Richmond Community Hospital LLC
Richmond, Virginia, 23226
United States
University of Washington - Harborview Medical Center
Seattle, Washington, 98104
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 Date2020-12-18
Study Completion Date2027-04

Study Record Updates

Study Start Date2020-12-18
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • Pruritus
  • PSC
  • Itch
  • Itching
  • Cholestasis

Additional Relevant MeSH Terms

  • Primary Sclerosing Cholangitis