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

Trial Profile

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

Completed
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
  • Most Recent Events

    • 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.
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