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
Phase of Trial: Phase III
Latest Information Update: 27 Feb 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
- 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.
- 30 Oct 2016 Results of post-hoc analysis comparing hepatic toxicity profiles of isavuconazole and voriconazole in patients in the SECURE study with and without allo-SCT, presented at the IDWeek 2016.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History