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)

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)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Jul 2018

At a glance

  • Drugs A 4250 (Primary)
  • Indications Intrahepatic cholestasis
  • Focus Registrational; Therapeutic Use
  • Acronyms PEDFIC-1
  • Sponsors Albireo Pharma
  • Most Recent Events

    • 16 May 2018 According to an Albireo Pharma media release, the company today announced the first patient has been enrolled and Professor Richard Thompson, King's college London is principal investigator of the study.
    • 16 May 2018 Status changed from planning to recruiting, according to an Albireo Pharma media release.
    • 14 Apr 2018 According to an Albireo Pharma media release, A4250 has been granted orphan drug designation for PFIC in the United States and European Union. The European Medicines Agency (EMA) has also granted A4250 access to the PRIority MEdicines (PRIME) program for the treatment of PFIC, and its Paediatric Committee has agreed to Albireo's A4250 Pediatric Investigation Plan.
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