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

Not Applicable

Completed

• Conditions: -B44 Aspergillosis; Aspergillosis; B44

• Registration Number: PER-002-99-A
• Lead Sponsor: FUJISAWA HEALTH CARE INC,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 1999-08-24
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Prior to inclusion, informed consent must be obtained from the patient or the legally authorized representative. An agreement will be obtained from the underage patients able to understand.
• Patients can be of any sex. Female patients of childbearing age must have a negative pregnancy test.
• Patients must have a proven or probable systemic infection caused by Aspergillus species (see Appendix A for diagnostic criteria).
• Patients must have adequate venous access to allow the administration of FK463 and the monitoring of safety variables.

Exclusion Criteria

• Pregnant or breastfeeding patients. Women of childbearing age should avoid pregnancy while receiving treatment with the drug being studied.
• Patients with any of the following abnormal liver test parameters: 1. AST or ALT> 10 times above the normal (ULN) limit 2. Total bilirubin> 5 times ULN 3. Alkaline phosphatase> 5 times ULN
• Patients with allergic bronchopulmonary aspergillosis, aspergillomas, paranasal aspergillosis or external otitis who have no histopathological evidence of tissue invasion.
• Patients with a life expectancy considered less than 5 days.
• Patients with a history of allergies, hypersensitivity or any serious reaction to the class of echinocandin antiflmgicos.
• Patients who have participated in this study before.
• Patients with a concomitant medical condition, according to the opinion of the investigator and / or clinical monitor, whose participation may create an additional risk unacceptable to the patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified