๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-24

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) (NCT04663308)

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

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Mirum Pharmaceuticals, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Southern California Research Center โ€” Coronado, California

Age range: 12 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (103 Sites)

Showing the first 25 of 103 sites.

  • Southern California Research Center โ€” Coronado, California
  • Cedars Sinai Medical Center โ€” Los Angeles, California
  • University of California, Davis โ€” Sacramento, California
  • California Pacific Medical Center Research Institute โ€” San Francisco, California
  • University of Colorado - Anschutz Medical Campus โ€” Aurora, Colorado
  • MedStar Georgetown University Hospital โ€” Washington D.C., District of Columbia
  • Florida Research Institute โ€” Lakewood Rch, Florida
  • University of Miami - Schiff Center for Liver Diseases โ€” Miami, Florida
  • Tampa General Hospital โ€” Tampa, Florida
  • Beth Israel Deaconess Medical Center โ€” Boston, Massachusetts
  • Henry Ford Hospital โ€” Detroit, Michigan
  • Mayo Clinic โ€” Rochester, Minnesota
  • Southern Therapy and Advanced Research LLC โ€” Jackson, Mississippi
  • Northwell Health โ€” Manhasset, New York
  • New York University Langone Health โ€” New York, New York
  • Weill Cornell Medical College โ€” New York, New York
  • Columbia University Medical Center - Presbyterian Hospital and Vanderbilt Clinic โ€” New York, New York
  • University of Rochester Medical Center - Strong Memorial Hospital โ€” Rochester, New York
  • Duke Health - Duke University Medical Center โ€” Durham, North Carolina
  • Science 37, Inc (Remote-homebased Telemedicine) โ€” Morrisville, North Carolina
  • Cleveland Clinic โ€” Cleveland, Ohio
  • Einstein Healthcare Network - Einstein Medical Center โ€” Philadelphia, Pennsylvania
  • University of Pittsburgh Medical Center โ€” Pittsburgh, Pennsylvania
  • Galen Medical Group โ€” Hixson, Tennessee
  • Vanderbilt University Medical Center โ€” Nashville, Tennessee

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—