Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

• Status: Completed
• Trial end date: 2013-03-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Basilea Pharmaceutica International Ltd
• Treatments: Isavuconazole; Voriconazole

Criteria

Inclusion Criteria:

• Patients must have proven, probable or possible invasive fungal disease caused by Aspergillus species or other filamentous fungi

• Female patients must be non-lactating and at no risk for pregnancy

Exclusion Criteria:

• Patients with invasive fungal infections other than Aspergillus species or other filamentous fungi

• Evidence of hepatic dysfunction at Baseline or moderate to severe renal dysfunction

• Patients with chronic aspergillosis, or aspergilloma or allergic bronchopulmonary aspergillosis

• Patients who have received more than 4 days of systemic antifungal therapy other than fluconazole within the 7 days prior to the first administration of study medication

• Patients previously enrolled in a Phase III study with isavuconazole

• Patients with a body weight