A Phase 3, Randomized, Multi-Center, Multi-National, Double-Blind Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once Daily Versus Twice Daily Dosing of Genz-112638 in Patients With Gaucher Disease Type 1 Who Have Demonstrated Clinical Stability on a Twice Daily Dose of Genz-112638
Latest Information Update: 17 Sep 2021
At a glance
- Drugs Eliglustat (Primary)
- Indications Gaucher's disease type I
- Focus Registrational; Therapeutic Use
- Acronyms EDGE
- Sponsors Genzyme Corporation
- 04 Dec 2018 Results analyzing bone mineral density T- and Z-scores and occurrence of bone pain and bone crises in 4 clinical trials (NCT00358150, NCT00891202, NCT00943111, and NCT01074944) presented at the 60th Annual Meeting and Exposition of the American Society of Hematology
- 04 Dec 2018 Results of long term pooled safety analysis (n=393) of ENGAGE, ENCORE, EDGE and one other phase II trial presented at the 60th Annual Meeting and Exposition of the American Society of Hematology
- 31 Jan 2018 According to a Genzyme Corporation media release, data form the study will be presented at the 14thAnnual WORLDSymposium.