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.
- Conditions
- Invasive fungal disease caused by Aspergillus species or other filamentous fungi.MedDRA version: 14.1 Level: PT Classification code 10003488 Term: Aspergillosis System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2006-003868-59-GB
- Lead Sponsor
- Astellas Pharma Global Development, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 510
•Patients must have probable or proven invasive fungal disease caused by Aspergillus species or other filamentous fungi
•Female patients must be non-lactating and at no risk for pregnancy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Patients with invasive fungal infections other than Aspergillus species or other filamentous fungi
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method