CLINICAL TRIALS PROFILE FOR CERDELGA
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All Clinical Trials for CERDELGA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02536755 ↗ | Study of Skeletal Response to Eliglustat in Patients With Gaucher Disease | Completed | Genzyme, a Sanofi Company | Phase 3 | 2015-10-28 | Primary Objective: Evaluate long term skeletal response to eliglustat in adult patients who successfully completed one of the Phase 2 or Phase 3 eliglustat studies. Secondary Objective: Evaluate the safety of eliglustat (by [serious] adverse event [AE] continuous monitoring), the quality of life (Short Form-36 Health Survey [SF-36]) and biomarkers of Gaucher disease type 1 (GD1) (chitotriosidase, plasma glucosylceramide [GL-1] and lyso glucosylceramide [lyso-GL-1]) in adult patients who successfully completed one of the Phase 2 or Phase 3 studies. |
| NCT03485677 ↗ | Safety and Efficacy of Eliglustat With or Without Imiglucerase in Pediatric Patients With Gaucher Disease (GD) Type 1 and Type 3 | Recruiting | Sanofi | Phase 3 | 2018-04-11 | Primary Objective: Evaluate the safety and pharmacokinetics of eliglustat in pediatric patients (≥2 to <18 years old). Secondary Objective: Evaluate the efficacy of eliglustat and quality of life in pediatric patients (≥2 to <18 years old). |
| NCT03519646 ↗ | Eliglustat on Gaucher Disease Type IIIB | Unknown status | Sanofi | N/A | 2018-04-23 | Evaluation of the safety in the combination usage of Cerdelga and Cerezyme in type III Gaucher disease patients and the efficacy on soft tissue diseases. |
| NCT03519646 ↗ | Eliglustat on Gaucher Disease Type IIIB | Unknown status | National Taiwan University Hospital | N/A | 2018-04-23 | Evaluation of the safety in the combination usage of Cerdelga and Cerezyme in type III Gaucher disease patients and the efficacy on soft tissue diseases. |
| NCT06143904 ↗ | A Study to Evaluate Absolute Bioavailability, Absorption, Metabolism, and Excretion of Genz-112638 in Healthy Male Participants | Completed | Sanofi | Phase 1 | 2009-06-03 | Objectives: To determine pharmacokinetic (PK) variables, including absolute bioavailability (F), of Genz-99067, the free base of the L-tartaric acid salt of Genz-112638 as it exists in plasma, after a single intravenous (IV) dose and after a single oral dose of Genz-112638 (unlabeled). To determine the PK, total recovery, routes and rates of excretion, and the metabolic profile of Genz-99067 after 5 days of BID oral dosing with unlabeled Genz-112638 followed by a single dose of [14C]-Genz-112638. |
| NCT06188325 ↗ | A Study to Evaluate Pharmacokinetic Parameters of Eliglustat in Healthy Volunteers Who Are CYP2D6 Extensive or Poor Metabolizers | Completed | Sanofi | Phase 1 | 2018-01-01 | The primary objective of the study is to evaluate dose proportionality and pharmacokinetics for three different dose levels of eliglustat after single and repeated administration. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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