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A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi

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Trial Profile

A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jan 2022

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At a glance

  • Drugs Isavuconazonium (Primary) ; Isavuconazonium (Primary) ; Voriconazole; Voriconazole
  • Indications Aspergillosis; Invasive bronchopulmonary aspergillosis; Mycoses; Zygomycosis
  • Focus Registrational; Therapeutic Use
  • Acronyms SECURE
  • Sponsors Astellas Pharma; Basilea Pharmaceutica

    • Most Recent Events

    • 14 Dec 2021 Results Post-Hoc Analysis from the VITAL and SECURE, presented at the 63rd American Society of Hematology Annual Meeting and Exposition
    • 25 Oct 2020 Results of post-hoc analysis of this trial, presented at the IDWeek 2020.
    • 02 May 2019 According to an AVIR Pharma Inc media release, Health Canada's approval of Cresemba was based on data from two Phase 3 clinical trials in adult patients with invasive fungal infections - SECURE and VITAL trials.

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