Study of FK463 for the Treatment of Invasive Aspergillosis

Astellas

Status and phase: Completed; Phase 2

Conditions: Aspergillosis

Treatments: Drug: FK463

Study type: Interventional

Funder types: Industry

Identifiers

NCT00036166

FG463-21-01

98-0-046 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 326 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)