CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 101 enrolled
Drug / intervention
Avalglucosidase alfa (GZ402666) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02782741
NCT02782741Phase 3Completed
CompareCT.gov

A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Safety of Repeated Biweekly Infusions of Avalglucosidase Alfa (neoGAA, GZ402666) and Alglucosidase Alfa in Treatment naïve Patients With Late-onset Pompe Disease

Genzyme, a Sanofi Company·interventional·Posted May 25, 2016·Updated Apr 4, 2024

In Brief

A Phase 3 clinical trial evaluating Avalglucosidase alfa (GZ402666) and Alglucosidase alfa (GZ419829) for Glycogen Storage Disease Type II;Pompe's Disease. Completed, enrolled 101 participants across 69 sites in 25 countries.

Detailed Summary

Primary 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlycogen Storage Disease Type II;Pompe's Disease
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Russia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 25, 2016
Enrollment StartNov 2, 2016
Primary CompletionMar 19, 2020
Study CompletionMay 31, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.1 years ago

Interventions

Avalglucosidase alfa (GZ402666)drug

Pharmaceutical form: powder for concentrate for solution for infusion Route of administration: intravenous

Alglucosidase alfa (GZ419829)drug

Pharmaceutical form: powder for concentrate for solution for infusion Route of administration: intravenous