Safety and Efficacy of Eliglustat With or Without Imiglucerase in Pediatric Patients With Gaucher Disease (GD) Type 1 and Type 3
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
57actual
Sites
21
Countries
Argentina, Canada, France +7
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2018-04-11 | actual | When the study began enrolling |
| Primary completion | 2025-12-26 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-26 | actual | The whole study's end, after follow-up |
| First posted | 2018-04-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Gaucher's Disease Type I
- Gaucher's Disease Type III
Interventions
- Drug: Eliglustat GZ385660 — also filed as Cerdelga
- Drug: Imiglucerase GZ437843 — also filed as Cerezyme
Primary outcomes
what the primary-completion date above is the date OFAssessment of pharmacokinetic (PK) parameter of eliglustat: Cmax
measured Weeks 2, 13, 26 and 52
Assessment of PK parameter of eliglustat: AUC
measured Weeks 2 and 52
Adverse Events
measured Up to Week 364
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