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A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects With Primary Sclerosing Cholangitis (PSC)

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Trial Profile

A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects With Primary Sclerosing Cholangitis (PSC)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 09 Jan 2023

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At a glance

  • Drugs Berberine ursodeoxycholate (Primary)
  • Indications Primary sclerosing cholangitis
  • Focus Proof of concept; Therapeutic Use
  • Sponsors HighTide Biopharma

    • Most Recent Events

    • 05 Jan 2023 According to HighTide Therapeutics media release, a successful end-of-phase 2 (EOP2) meeting was held with the U.S Food and Drug Administration (FDA) based on the positive findings from this study in primary sclerosing cholangitis.
    • 08 Nov 2022 Results assessing the impact of disease severity based on alkaline phosphatase at baseline on treatment with HTD1801 in patients with primary sclerosing cholangitis, presented at The Liver Meeting 2022: 73rd Annual Meeting of the American Association for the Study of Liver Diseases.
    • 01 Nov 2022 Results published in the American Journal of Gastroenterology
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