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An Open-Label, Multicenter, Multinational Extension Study Of The Long-Term Safety And Pharmacokinetics Of Repeated Biweekly Infusions Of Avalglucosidase Alfa (NeoGAA, GZ402666) In Patients With Pompe Disease

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Trial Profile

An Open-Label, Multicenter, Multinational Extension Study Of The Long-Term Safety And Pharmacokinetics Of Repeated Biweekly Infusions Of Avalglucosidase Alfa (NeoGAA, GZ402666) In Patients With Pompe Disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Mar 2024

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At a glance

  • Drugs Avalglucosidase alfa (Primary)
  • Indications Glycogen storage disease type II
  • Focus Adverse reactions; Biomarker
  • Acronyms NEO-EXT
  • Sponsors Sanofi; Sanofi Genzyme

    • Most Recent Events

    • 05 Feb 2024 According to a Sanofi media release, positive long-term results from this study will be featured at WORLDSymposiumTM 2024.
    • 01 Dec 2023 Population PK (PopPK) analysis was performed using nonlinear mixed effect modeling approach on pooled data from three clinical trials (NCT01898364, NCT02032524 and NCT02782741) with LOPD patients, and a phase 2 study (NCT03019406) with infantile-onset Pompe disease patients to propose alternative dosing regimens for pediatric LOPD patients based on a bodyweight cut-off,, published in the Journal of Pharmacokinetics and Pharmacodynamics.
    • 14 Dec 2022 Status changed from active, no longer recruiting to completed.

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