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
Phase of Trial: Phase III
Latest Information Update: 08 Feb 2017
At a glance
- Drugs Eliglustat (Primary)
- Indications Gaucher's disease type I
- Focus Registrational; Therapeutic Use
- Acronyms EDGE
- Sponsors Genzyme Corporation
- 09 Dec 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
- 30 Apr 2015 Cerdelga (eliglustat) was approved for the treatment of adults with Gaucher disease type 1 in the USA, Japan (March) and Australia (February) based on results of the phase III ENGAGE, ENCORE and EDGE studies.
- 30 Mar 2015 Patients are continuing to receive Cerdelga in the extension period, with most patients in their 4th or 5th year of treatment, according to a Genzyme Corporation media release.