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A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy & Safety of Oral GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and With Persistently Elevated Alkaline Phosphatase

Trial Profile

A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy & Safety of Oral GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and With Persistently Elevated Alkaline Phosphatase

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 27 Jun 2022

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At a glance

  • Drugs Setanaxib (Primary)
  • Indications Cholangitis; Primary biliary cirrhosis
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Calliditas Therapeutics; GenKyoTex

Most Recent Events

  • 26 Jun 2022 Results of a post hoc analysis assessed quality of life presented at The International Liver Congress 2022
  • 15 Nov 2021 Results of post-hoc efficacy analysis presented at The Liver Meeting 2021: 72nd Annual Meeting of the American Association for the Study of Liver Diseases.
  • 18 Jun 2020 According to an Abeona Therapeutics media release, Genkyotex will submit the new data from this study for presentation at major international liver conferences.

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