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A Phase 1/2, Open-Label, Ascending-Dose Clinical Study to Evaluate the Safety and Preliminary Efficacy of AT845, an AAV8-Delivered Gene Transfer Therapy in Patients With Late Onset Pompe Disease

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Trial Profile

A Phase 1/2, Open-Label, Ascending-Dose Clinical Study to Evaluate the Safety and Preliminary Efficacy of AT845, an AAV8-Delivered Gene Transfer Therapy in Patients With Late Onset Pompe Disease

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 Aug 2024

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At a glance

  • Drugs Zocaglusagene nuzaparvovec (Primary)
  • Indications Glycogen storage disease type II
  • Focus Adverse reactions; First in man; Pharmacodynamics
  • Acronyms FORTIS
  • Sponsors Astellas Gene Therapies

    • Most Recent Events

    • 19 Aug 2024 Planned number of patients changed from 12 to 18.
    • 19 Aug 2024 Planned End Date changed from 30 Sep 2029 to 30 Nov 2029.
    • 19 Aug 2024 Planned primary completion date changed from 30 Sep 2029 to 30 Nov 2029.

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