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Phase 3, Open-Label, Single-Arm, Single-Dose Gene Replacement Therapy Clinical Trial for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies Delivering AVXS-101 by Intravenous Infusion

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Trial Profile

Phase 3, Open-Label, Single-Arm, Single-Dose Gene Replacement Therapy Clinical Trial for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies Delivering AVXS-101 by Intravenous Infusion

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Aug 2022

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At a glance

  • Drugs Onasemnogene-abeparvovec (Primary)
  • Indications Spinal muscular atrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms STR1VE EU
  • Sponsors AveXis; Novartis Gene Therapies

Most Recent Events

  • 13 Mar 2022 Results of post-hoc analysis from START, STR1VE-EU and STR1VE-US studies were presented at Novartis media release.
  • 22 Jun 2021 Final results presented at the 7th Congress of the European Academy of Neurology
  • 18 Jun 2021 According to a Novartis media release, data from this trial will be presented at the European Academy for Neurology (EAN) Virtual Congress 2021.

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