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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: 10 Dec 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

    • 10 Dec 2018 According to a Genethon media release, the company has treated the first patient in this study.
    • 27 Sep 2018 Planned End Date changed from 31 Aug 2020 to 31 Dec 2020.
    • 27 Sep 2018 Planned primary completion date changed from 31 Aug 2020 to 31 Dec 2020.
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