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A Phase 2 Open Label, Proof of Concept Study of HTD1801 (BUDCA) in Adult Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to Standard Therapy - PRONTO-PBC

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Trial Profile

A Phase 2 Open Label, Proof of Concept Study of HTD1801 (BUDCA) in Adult Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to Standard Therapy - PRONTO-PBC

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Apr 2024

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At a glance

  • Drugs Berberine ursodeoxycholate (Primary)
  • Indications Cholestasis; Primary biliary cirrhosis; Primary sclerosing cholangitis
  • Focus Proof of concept; Therapeutic Use
  • Acronyms PRONTO-PBC
  • Sponsors HighTide Biopharma

Most Recent Events

  • 24 Jun 2022 Status changed from recruiting to completed.
  • 06 Oct 2021 Planned End Date changed from 31 Jan 2022 to 30 Apr 2022.
  • 06 Oct 2021 Planned primary completion date changed from 31 Dec 2021 to 31 Mar 2022.

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