Clinical trial
Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies…
NCT02782741 · Genzyme, a Sanofi Company, Industry · Completed
Key facts
| NCT number | NCT02782741 |
|---|---|
| Title | 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 |
| Official title | 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 |
| Acronym | COMET |
| Lead sponsor | Genzyme, a Sanofi Company, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Glycogen Storage Disease Type II, Pompe's Disease |
| Intervention type | Drug |
| Interventions | Avalglucosidase alfa (GZ402666), Alglucosidase alfa (GZ419829) |
| Enrollment | 101 |
| Start date | Nov 2, 2016 |
| Primary completion | Mar 19, 2020 |
| Completion | May 31, 2023 |
| First posted | May 25, 2016 |
| Last update posted | Apr 4, 2024 |
| Countries | Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Hungary, Italy and 13 more |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: