At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 527 enrolled
Drug / intervention
Isavuconazole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Isavuconazole and Voriconazole for Aspergillosis and Invasive Fungal Infection. Completed, enrolled 527 participants across 107 sites in 26 countries.
Detailed Summary
The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAspergillosis, Invasive Fungal Infection
CountriesArgentina, Australia, Belgium, Brazil, Canada, Chile, China, Egypt, France, Germany, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, New Zealand, Poland, Russia, South Korea, Spain, Switzerland, Thailand, Turkey (Türkiye), United States
CollaboratorsBasilea Pharmaceutica International Ltd
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2006
Enrollment StartMar 2007
Primary CompletionMar 2013
TodayJul 2026
First PostedDec 19, 2006
Enrollment StartMar 7, 2007
Primary CompletionMar 28, 2013
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 19.5 years ago
Interventions
Isavuconazoledrug
Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
Voriconazoledrug
Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).