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A Phase IV Open-label, Single-arm, Single-dose, Multicenter Study to Evaluate the saFEty, toLerability and effIcacy of Gene Replacement Therapy With intravenousOAV101(AVXS101) in Pediatric Patients From Latin America With Spinal Muscular Atrophy (SMA) - OFELIA

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A Phase IV Open-label, Single-arm, Single-dose, Multicenter Study to Evaluate the saFEty, toLerability and effIcacy of Gene Replacement Therapy With intravenousOAV101(AVXS101) in Pediatric Patients From Latin America With Spinal Muscular Atrophy (SMA) - OFELIA

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 06 Jun 2024

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At a glance

  • Drugs Onasemnogene-abeparvovec (Primary)
  • Indications Spinal muscular atrophy
  • Focus Adverse reactions
  • Acronyms OFELIA
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 30 Aug 2023 Status changed from active, no longer recruiting to completed.
    • 18 Jul 2023 Planned End Date changed from 30 Jun 2023 to 31 Jul 2023.
    • 18 Jul 2023 Planned primary completion date changed from 30 Jun 2023 to 31 Jul 2023.

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