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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

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: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 27 Mar 2025

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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

  • 05 Mar 2025 Planned End Date changed from 30 Nov 2029 to 28 Feb 2030.
  • 05 Mar 2025 Planned primary completion date changed from 30 Nov 2029 to 28 Feb 2030.
  • 05 Mar 2025 Status changed from recruiting to active, no longer recruiting.

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