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NCT02782741 · ClinicalTrials.gov registry record · 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
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
NCT02782741: Completed Phase 3 study, sponsored by Genzyme, a Sanofi Company.
NCT02782741 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 101 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02782741, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
Study 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).
Primary Outcome
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air (in liters) that can be forcibly blown out after full inspiration in the upright position. Least square (LS) mean and standard error (SE) were derived from mixed model for repeated measure (MMRM) model with baseline FVC \[percent (%) predicted, as continuous\], sex, age (in years at baseline), treatment group, visit, interaction term between treatment group and visit as fixed effects.
Interventions
- DRUG Avalglucosidase alfa (GZ402666)
- DRUG Alglucosidase alfa (GZ419829)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2016-11-02 |
| Est. Completion | 2023-05-31 |
| Phase | Phase 3 |
What the finished NCT02782741 record still lists
NCT02782741 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Avalglucosidase alfa (GZ402666) is the first listed.
NCT02782741 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02782741 about?
NCT02782741 is a clinical study titled "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". 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 avalgluc...
What is the current status of trial NCT02782741?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2016-11-02. Estimated completion is 2023-05-31.
What interventions are being tested in trial NCT02782741?
The interventions under investigation include: Avalglucosidase alfa (GZ402666) (DRUG), Alglucosidase alfa (GZ419829) (DRUG).
Who is sponsoring clinical trial NCT02782741?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02782741's enrollment target sits among peer trials
101 1680th of 2000 higher than 320 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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