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A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz-112638 in Patients With Gaucher Disease Type 1 Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)

Trial Profile

A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz-112638 in Patients With Gaucher Disease Type 1 Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jun 2019

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At a glance

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

    • 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
    • 06 Feb 2017 Results (n=46) assessing long-term (4 years) safety and efficacy of eliglustat, published in the Blood.
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