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Alglucosidase alfa (GZ419829)

DRUG2 trials

Sponsors

Genzyme, a Sanofi Company

Conditions

Glycogen Storage Disease Type II-Pompe's DiseaseGlycogen Storage Disease Type II;Pompe's Disease

Phase 2

A Study to Assess Safety and Efficacy of Avalglucosidase Alfa Administered Every Other Week in Pediatric Patients With Infantile-onset Pompe Disease Previously Treated With Alglucosidase Alfa
Active, not recruitingNCT03019406
Genzyme, a Sanofi CompanyGlycogen Storage Disease Type II-Pompe's Disease
Start: 2017-10-12End: 2027-08-10Updated: 2026-01-30

Phase 3

Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease
CompletedNCT02782741
Genzyme, a Sanofi CompanyGlycogen Storage Disease Type II;Pompe's Disease
Start: 2016-11-02End: 2023-05-31Updated: 2024-04-04

Related Papers

An Indirect Treatment Comparison of Avalglucosidase Alfa versus Cipaglucosidase Alfa Plus Miglustat in Patients with Late-Onset Pompe Disease.
2025-09-08
Efficacy and safety of avalglucosidase alfa in patients with late-onset Pompe disease after 145 weeks of treatment during the COMET trial.
2025-08-161 citations
Efficacy of Switching Therapy From Alglucosidase Alfa to Avalglucosidase Alfa on Respiratory Function in Participants With Late‐Onset Pompe Disease: A Post Hoc Analysis From the <scp>COMET</scp> Trial
JIMD Reports2025-08-121 citations
The Mini-COMET Clinical Trial: Safety and Efficacy of Avalglucosidase Alfa after 97 Weeks of Treatment in Children with Infantile-Onset Pompe Disease Previously Treated with Alglucosidase Alfa.
2025-05-291 citations
Defining clinically meaningful thresholds for forced vital capacity in patients with neuromuscular disorders: Lessons learned from the COMET study in Pompe disease
Journal of Neuromuscular Diseases2025-05-212 citations
QSP-based virtual twin approach provides mechanistic insight into enzyme replacement therapies in Pompe Disease
2025-02-18
Efficacy of avalglucosidase alfa on forced vital capacity percent predicted in treatment-naïve patients with late-onset Pompe disease: A pooled analysis of clinical trials.
2024-06-264 citations
Безопасность и эффективность авалглюкозидазы альфа по сравнению с алглюкозидазой альфа у пациентов с болезнью Помпе с поздним началом: рандомизированное многоцентровое исследование III фазы COMET
Neuromuscular Diseases2024-01-05
Effect of avalglucosidase alfa on disease-specific and general patient-reported outcomes in treatment-naïve adults with late-onset Pompe disease compared with alglucosidase alfa: Meaningful change analyses from the Phase 3 COMET trial.
2023-12-2715 citations
Measurement Properties of 2 Novel PROs, the Pompe Disease Symptom Scale and Pompe Disease Impact Scale, in the COMET Study
Neurology Clinical Practice2023-08-088 citations
Population pharmacokinetic modeling and dosing simulation of avalglucosidase alfa for selecting alternative dosing regimen in pediatric patients with late-onset pompe disease
Journal of Pharmacokinetics and Pharmacodynamics2023-08-034 citations
2595 Efficacy and safety of avalglucosidase Alfa in participants with late-onset pompe disease after 145 weeks’ treatment: phase 3 COMET trial
2023-08-012 citations
Efficacy and Safety of Avalglucosidase Alfa in Patients With Late-Onset Pompe Disease After 97 Weeks
JAMA Neurology2023-04-1047 citations
Safety and efficacy of avalglucosidase alfa in individuals with infantile-onset Pompe disease enrolled in the phase 2, open-label Mini-COMET study: The 6-month primary analysis report.
2022-12-2136 citations
2285 Efficacy and safety of avalglucosidase alfa in participants with late-onset pompe disease after 97 weeks of treatment during the COMET trial
Abstracts2022-08-01
Long-term Safety and Efficacy of Avalglucosidase Alfa in Patients With Late-Onset Pompe Disease
Neurology2022-06-0242 citations
Safety and efficacy of avalglucosidase alfa versus alglucosidase alfa in patients with late-onset Pompe disease (COMET): a phase 3, randomised, multicentre trial.
2021-12-01119 citations
P.025 Efficacy and safety results of the avalglucosidase alfa phase 3 COMET trial in participants with late-onset Pompe disease (LOPD)
Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques2021-11-01