A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Confirming the Efficacy and Safety of Genz-112638 in Patients With Gaucher Disease Type 1 (ENGAGE)

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Confirming the Efficacy and Safety of Genz-112638 in Patients With Gaucher Disease Type 1 (ENGAGE)

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Mar 2017

At a glance

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

    • 01 Apr 2016 Status changed from active, no longer recruiting to completed according to the European Clinical Trials Database record.
    • 08 Dec 2015 Results of this and two other trials (see profile 239259 and 239253) presented at the 57th Annual Meeting and Exposition of the American Society of Hematology
    • 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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