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An Exploratory, Phase IIa Cross-Over Study to Demonstrate the Efficacy and Safety of A4250 in Patients with Primary Biliary Cirrhosis and Cholestatic Pruritus

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Trial Profile

An Exploratory, Phase IIa Cross-Over Study to Demonstrate the Efficacy and Safety of A4250 in Patients with Primary Biliary Cirrhosis and Cholestatic Pruritus

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 03 Aug 2023

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At a glance

  • Drugs Odevixibat (Primary)
  • Indications Primary biliary cirrhosis; Pruritus
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 27 Jul 2023 According to an Ipsen Media Release, The Committee for Orphan Medicinal Products (COMP), a scientific committee of the EMA, concurrently issued a negative opinion for the maintenance of Bylvays orphan drug designation in ALGS. This latter opinion prevents the retention of orphan-drug status in Bylvays marketing authorization in ALGS and might delay a final European Commission decision. Ipsen plans to submit an appeal in respect of the COMP opinion.
  • 24 Oct 2017 Results presented at The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases
  • 15 Oct 2016 Status changed from recruiting to discontinued.

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