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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

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: 29 Jul 2019

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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

    • 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.
    • 29 Nov 2017 Results (n=142) of post hoc analysis assessing safety and efficacy of isavuconazole in neutropenic patients with invasive aspergillosis published in the Journal of Antimicrobial Chemotherapy
    • 11 Jan 2017 Results from NCT00412893 (post hoc analysis; n=257) and NCT01565720 (n=161) studies assessing effect of isavuconazole on cardiac repolarization; published in the Clinical Pharmacology and Therapeutics.
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