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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 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 101 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02782741
The ClinicalTrials.gov registry entry for NCT02782741 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Avalglucosidase alfa (GZ402666) is the first listed.
NCT02782741 reports 0 study locations.
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.
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