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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Jun 2025

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At a glance

  • Drugs Volixibat (Primary)
  • Indications Intrahepatic cholestasis; Primary sclerosing cholangitis
  • Focus Registrational; Therapeutic Use
  • Acronyms VISTAS
  • Sponsors Mirum Pharmaceuticals

Most Recent Events

  • 13 Jan 2025 According to a Mirum Pharmaceuticals media release, trial expected to complete enrollment in second half 2025 and topline data expected in 2026.
  • 17 Jun 2024 According to a Mirum Pharmaceuticals media release, interim analysis for the VISTAS PSC study was conducted and the independent data review committee recommended that the study continue with the selected volixibat dose of 20 mg twice daily, with no changes to the study. The criteria for continuation included safety as well as a predefined threshold for efficacy. The sponsor and investigators are blinded to the interim results and analysis.
  • 17 Jun 2024 According to a Mirum Pharmaceuticals media release, the company to host a conference call to discuss a interim analysis of VISTAS and VANTAGE on Monday, June 17 at 8:30 a.m. ET/5:30 a.m. Kris Kowdley is investigator in this trial.

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