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An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2)

Trial Profile

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Oct 2025

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At a glance

  • Drugs Odevixibat (Primary)
  • Indications Intrahepatic cholestasis
  • Focus Registrational; Therapeutic Use
  • Acronyms PEDFIC 2
  • Sponsors Albireo AB; Albireo Pharma

Most Recent Events

  • 18 Sep 2025 Planned End Date changed from 15 Aug 2025 to 10 Oct 2025.
  • 10 Jul 2025 Planned End Date changed from 31 Mar 2025 to 15 Aug 2025.
  • 18 Nov 2024 According to Ipsen media release, efficacy and safety data from this study will be presented at the American Association for the Study of Liver Diseases (AASLD).

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