At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 19 enrolled
Drug / intervention
Avalglucosidase Alfadrug
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.
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
In Brief
A Phase 2 clinical trial evaluating Avalglucosidase Alfa for Glycogen Storage Disease Type II Pompe Disease. Completed, enrolled 19 participants across 17 sites in 7 countries.
Detailed Summary
Primary Objective: Long-term safety and pharmacokinetics (PK) of avalglucosidase alfa Secondary Objective: Long-term effect of avalglucosidase alfa on pharmacodynamic variables
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Denmark, France, Germany, Netherlands, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartFeb 2014
Primary CompletionDec 2022
TodayJul 2026
First PostedJan 10, 2014
Enrollment StartFeb 27, 2014
Primary CompletionDec 12, 2022
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 12.5 years ago
Interventions
Avalglucosidase Alfadrug
Pharmaceutical form: lyophilized powder reconstituted for infusion Route of administration: intravenous