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A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)

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Trial Profile

A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Mar 2024

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At a glance

  • Drugs Odevixibat (Primary)
  • Indications Intrahepatic cholestasis
  • Focus Registrational; Therapeutic Use
  • Acronyms PEDFIC 1
  • Sponsors Albireo AB; Albireo Pharma

    • Most Recent Events

    • 14 Nov 2023 Results (n=41) assessing to predict the responsiveness of odevixibat in the PEDFIC 1 trial (n=29) or the rollover PEDFIC 2 trial (n=12) to an IBATi in patients with PFIC2, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases.
    • 14 Nov 2023 Results assessing treatment effects in patient subgroups defined by demographic and baseline characteristics using pooled data from Pedfic 1 and Pedfic 2 trial presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases
    • 13 Nov 2023 According to Ipsen media release, the Health Canada approval for Bylvay (odevixibat) for the treatment of pruritus in patients aged 6 months or older with Progressive Familial Intrahepatic Cholestasis (PFIC) based upon this trial.

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