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

  • STATUS
    Recruiting
  • End date
    Dec 11, 2025
  • participants needed
    260
  • sponsor
    Mirum Pharmaceuticals, Inc.
Updated on 11 August 2022
bile acid
cholangitis

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.

Details
Condition Primary Biliary Cholangitis, PBC
Treatment Placebo, Volixibat
Clinical Study IdentifierNCT05050136
SponsorMirum Pharmaceuticals, Inc.
Last Modified on11 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 and anti-pruritic medication use will be allowed if meeting additional criteria
Qualified pruritus associated with PBC as assessed by Adult ItchRO

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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