Trial Information
An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis
This will be an open-label, non-comparative study of intravenous FK463. Enrollment will
include at least 100 patients evaluable for efficacy.
Inclusion Criteria
Inclusion Criteria
- Has proven or probable systemic infection with Aspergillus species
Exclusion Criteria
- Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
- Has bronchopulmonary aspergillosis, aspergillomas, sinus aspergillosis or external
otitis but does not have histologic evidence of tissue invasion
- Has life-expectancy judged to be less than 5 days
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
FG463-21-01
NCT ID:
NCT00036166
Start Date:
January 1999
Completion Date:
December 2002
Related Keywords:
- Aspergillosis
- Aspergillus
- Anti-Fungal
- Aspergillosis
