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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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Nov 2019

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At a glance

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

    • 06 Nov 2019 According to an Albireo Pharma media release, first patients in the second cohort has been enrolled.
    • 03 Oct 2019 According to an Albireo Pharma media release, the company expects topline data from PEDFIC program (PEDFIC 1 and PEDFIC 2) in mid-2020.There are currently 45 sites actively recruiting for the PEDFIC program.
    • 06 Sep 2019 Planned End Date changed from 1 Apr 2021 to 1 Dec 2021.
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