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Open-label, long-term follow-up of safety and biochemical disease control of Infacort in neonates, infants and children with congenital adrenal hyperplasia and adrenal insufficiency previously enrolled in the Infacort 003 study

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Trial Profile

Open-label, long-term follow-up of safety and biochemical disease control of Infacort in neonates, infants and children with congenital adrenal hyperplasia and adrenal insufficiency previously enrolled in the Infacort 003 study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Hydrocortisone (Primary)
  • Indications Adrenal insufficiency; Congenital adrenal hyperplasia
  • Focus Adverse reactions; Registrational
  • Acronyms Infacort004
  • Sponsors Diurnal

Most Recent Events

  • 20 Sep 2018 Status changed from active, no longer recruiting to completed.
  • 13 Feb 2018 According to a Diurnal media release, received paediatric use marketing authorisation (PUMA) for Alkindi from the European Commission (EC).
  • 15 Dec 2017 According to a Diurnal media release, the CHMP of the EMA, has issued a positive opinion to the European Commission recommending Alkindi (Infacort hydrocortisone granules in capsules for opening) as replacement therapy for paediatric adrenal insufficiency. The positive opinion from the CHMP is based on review of data from this trial. The final decision on the paediatric use marketing authorisation (PUMA) from the European Commission is anticipated in February 2018.

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