Clinical trial
Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa…
NCT02004691 · Genzyme, a Sanofi Company, Industry · Completed
Key facts
| NCT number | NCT02004691 |
|---|---|
| Title | Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency |
| Official title | A Phase 2/3, Multicenter, Randomized, Double-blinded, Placebo-controlled, Repeat-dose Study to Evaluate the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency |
| Acronym | ASCEND |
| Lead sponsor | Genzyme, a Sanofi Company, Industry |
| Status | Completed |
| Phase | Phase 2/Phase 3 |
| Study type | Interventional |
| Conditions | Sphingomyelin Lipidosis |
| Intervention type | Drug |
| Interventions | placebo (saline), Olipudase alfa |
| Enrollment | 36 |
| Start date | Dec 18, 2015 |
| Primary completion | Mar 15, 2021 |
| Completion | Oct 19, 2023 |
| First posted | Dec 9, 2013 |
| Last update posted | Nov 7, 2024 |
| Countries | Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, France, Germany, Italy, Japan, Netherlands, Portugal and 5 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: