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A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis

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Trial Profile

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Apr 2024

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At a glance

  • Drugs ASC 42 (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Therapeutic Use
  • Sponsors Gannex Pharma

    • Most Recent Events

    • 03 Apr 2024 Status changed from active, no longer recruiting to completed.
    • 03 Apr 2024 According to Ascletis Pharma media release, based on the results of this study the Company made a strategic decision not to pursue further clinical trials of ASC42 for PBC indication.the Company also decided not to pursue further clinical studies of ASC42 as an FXR agonist in combination for non-alcoholic steatohepatitis (NASH) (ASC43F) and clinical studies of ASC42 for hepatitis B virus (HBV) indication.
    • 20 Jul 2023 According to Gannex Pharma media release, topline data are expected to be available by the end of 2023.

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