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

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Nov 2017

At a glance

  • Drugs Isavuconazonium (Primary) ; Isavuconazonium (Primary) ; Voriconazole; Voriconazole
  • Indications Aspergillosis; Mycoses; Zygomycosis
  • Focus Registrational; Therapeutic Use
  • Acronyms SECURE
  • Sponsors Astellas Pharma; Basilea Pharmaceutica
  • Most Recent Events

    • 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.
    • 30 Oct 2016 Results of post-hoc analysis comparing hepatic safety profiles of isavuconazole and voriconazole in patients in the SECURE study with and without allo-BMT, presented at the IDWeek 2016.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top