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 (VISTAS)

  • STATUS
    Recruiting
  • End date
    Dec 18, 2025
  • participants needed
    200
  • sponsor
    Mirum Pharmaceuticals, Inc.
Updated on 18 September 2022

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

Details
Condition Primary Sclerosing Cholangitis
Treatment Placebo, Volixibat
Clinical Study IdentifierNCT04663308
SponsorMirum Pharmaceuticals, Inc.
Last Modified on18 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Provide freely signed informed consent and be willing to comply with all study visits and requirements through end of study, including the follow-up period
Subjects aged ≥18 years
Confirmed diagnosis of large duct or small duct PSC based on American Association for the Study of Liver Disease (AASLD) guidelines
Qualified pruritus associated with PSC as assessed by Adult ItchRO
Ursodeoxycholic acid (UDCA) and anti-pruritic medication use will be allowed if meeting additional criteria
Concomitant Inflammatory Bowel Disease (IBD) is allowed if meeting additional criteria

Exclusion Criteria

Pruritus associated with an etiology other than PSC
Evidence or clinical suspicion of decompensated cirrhosis, or a history of decompensation events
History of ileostomy or small bowel surgery/resection or other surgeries that may have disrupted the enterohepatic circulation
Evidence, history, or suspicion of other liver diseases
Bile duct stent or percutaneous bile duct drain placement, or balloon dilatation procedure of a stricture within 12 weeks of Screening
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
History of liver transplantation
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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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