Pivotal study of A4250 in children with progressive familial intrahepatic cholestasis

Trial Profile

Pivotal study of A4250 in children with progressive familial intrahepatic cholestasis

Planning
Phase of Trial: Phase III

Latest Information Update: 14 Nov 2017

At a glance

  • Drugs A 4250 (Primary)
  • Indications Intrahepatic cholestasis
  • Focus Registrational; Therapeutic Use
  • Sponsors Albireo Pharma
  • Most Recent Events

    • 14 Nov 2017 According to a company media release, Albireo submitted the study protocol and is currently addressing refinements suggested by the FDA, with no change to the key study design details previously announced. Albireo now expects to initiate this trial by the spring of 2018.
    • 21 Aug 2017 According to an Albireo Pharma media release, this trial is expected to begin by the end of 2017.
    • 18 May 2017 According to an Albireo Pharma media release, company has finalised key design for this study following consultations with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
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