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

a study on Primary Biliary Cholangitis Pruritus Cirrhosis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
study ends around

Description

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 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

Keywords

Primary Biliary Cholangitis, PBC, Pruritus, Itching, Cholangitis, Hepatobiliary disorders, Biliary Liver Cirrhosis, Digestive System Diseases, volixibat

Eligibility

You can join if…

Open to people ages 18 years and up

  • Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study
  • Male or female, age ≥18 years at the screening visit
  • Confirmed diagnosis of PBC in line with the AASLD guidelines
  • UDCA, anti-pruritic medication and PPAR agonist use will be allowed if meeting additional criteria
  • Qualified pruritus associated with PBC as assessed by Adult ItchRO

You CAN'T join if...

  • Pruritus associated with an etiology other than PBC
  • Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events
  • Current symptomatic cholelithiasis or inflammatory gallbladder disease
  • History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation.
  • Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded
  • History of Liver transplantation

Locations

  • UC Davis accepting new patients
    Sacramento California 95817 United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • Southern California Research Center terminated
    Coronado California 92218 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mirum Pharmaceuticals, Inc.
ID
NCT05050136
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 260 study participants
Last Updated
Contact us about this trial