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: 31 Jan 2018

At a glance

  • Drugs Eliglustat (Primary)
  • Indications Gaucher's disease type I
  • Focus Registrational; Therapeutic Use
  • Acronyms EDGE
  • Sponsors Genzyme Corporation
  • Most Recent Events

    • 31 Jan 2018 According to a Genzyme Corporation media release, data form the study will be presented at the 14thAnnual WORLDSymposium.
    • 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.
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