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A Phase 3, Multicenter, Multinational, Randomized, Double-blind, Double-dummy, Active-comparator Study to Evaluate the Efficacy and Safety of Venglustat in Adult and Pediatric Patients With Gaucher Disease Type 3 (GD3) Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ERT)

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A Phase 3, Multicenter, Multinational, Randomized, Double-blind, Double-dummy, Active-comparator Study to Evaluate the Efficacy and Safety of Venglustat in Adult and Pediatric Patients With Gaucher Disease Type 3 (GD3) Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ERT)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Jan 2025

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At a glance

  • Drugs Venglustat (Primary) ; Imiglucerase
  • Indications Gaucher's disease type III
  • Focus Registrational; Therapeutic Use
  • Acronyms LEAP2MONO
  • Sponsors Sanofi Genzyme; Sanofi-Aventis Recherche & Developpement

    • Most Recent Events

    • 04 Nov 2024 Status changed from recruiting to active, no longer recruiting.
    • 25 Jul 2024 According to a Sanofi media release, data expected in H2 2025.
    • 15 Dec 2023 Planned End Date changed from 29 Jan 2026 to 30 Oct 2026.

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