CareCN: A phase I/II, open label, escalating dose study to evaluate safety and efficacy of an intravenous injection of GNT0003 (Adeno-associated Viral Vector expressing the UGT1A1 transgene) in patients with severe Crigler-Najjar syndrome requiring phototherapy

Trial Profile

CareCN: A phase I/II, open label, escalating dose study to evaluate safety and efficacy of an intravenous injection of GNT0003 (Adeno-associated Viral Vector expressing the UGT1A1 transgene) in patients with severe Crigler-Najjar syndrome requiring phototherapy

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 25 May 2018

At a glance

  • Drugs GNT 0003 (Primary)
  • Indications Crigler-Najjar syndrome
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms CareCN
  • Sponsors Genethon
  • Most Recent Events

    • 15 May 2018 Status changed from not yet recruiting to recruiting.
    • 12 Feb 2018 According to a Genethon media release, this trial takes place in four investigation centres in Europe: France (Prof Labrune - Hopital Beclere in Clamart), Italy (Prof Brunetti -Pierri - Hopital Federico II, Prof dAntiga - Azienda Ospedaliera Papa Giovanni XXIII in Bergamo) and the Netherlands (Prof Beuers - Academic Medical Center in Amsterdam).
    • 24 Oct 2017 New trial record
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