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Avalglucosidase alfa · COMET

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

Ensayo de Sanofi en Glycogen Storage Disease Type II;Pompe's Disease (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

101

previstos

Centros

69

Fin del objetivo primario

mar 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en nov 2016.

Qué mide

PAP: Change From Baseline in Percent Predicted FVC in Upright Position at Week 49 (del registro, en inglés) (inicio y semana 49)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To determine the effect of avalglucosidase alfa treatment on respiratory muscle strength measured by percent (%) predicted forced vital capacity (FVC) in the upright position, as compared to alglucosidase alfa. Secondary Objective: To determine the safety and effect of avalglucosidase alfa treatment on functional endurance (6-minute walk test, inspiratory muscle strength (maximum inspiratory pressure), expiratory muscle strength (maximum expiratory pressure), lower extremity muscle strength (hand-held dynamometry), motor function (Quick Motor Function Test), and health-related quality of life (Short Form-12).

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Ficha completa en ClinicalTrials.gov (NCT02782741), actualizada en mar 2024.