Study of FK463 for the Treatment of Invasive Aspergillosis

An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis

The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with proven or probable invasive infections due to Aspergillus species.

This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.

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