Clinical trial
Safety, Tolerability, PK, and Efficacy Evaluation of Repeat Ascending Doses of…
NCT02292654 · Genzyme, a Sanofi Company, Industry · Completed
Key facts
| NCT number | NCT02292654 |
|---|---|
| Title | Safety, Tolerability, PK, and Efficacy Evaluation of Repeat Ascending Doses of Olipudase Alfa in Pediatric Patients <18 Years of Age With Acid Sphingomyelinase Deficiency |
| Official title | A Phase 1/2, Multi-Center, Open-Label, Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of Olipudase Alfa in Pediatric Patients Aged <18 Years With Acid Sphingomyelinase Deficiency |
| Acronym | ASCEND-Peds |
| Lead sponsor | Genzyme, a Sanofi Company, Industry |
| Status | Completed |
| Phase | Phase 1/Phase 2 |
| Study type | Interventional |
| Conditions | Sphingomyelin Lipidosis |
| Intervention type | Drug |
| Interventions | Olipudase alfa |
| Enrollment | 20 |
| Start date | May 1, 2015 |
| Primary completion | Dec 9, 2019 |
| Completion | Dec 9, 2019 |
| First posted | Nov 17, 2014 |
| Last update posted | Mar 23, 2022 |
| Countries | Brazil, France, Germany, Italy, United Kingdom, United States |
At a glance
- 1–9 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: