OPEN-LABEL, NON-COMPARATIVE STUDY OF FK463 IN THE TREATMENT OF INVASIVE ASPERGILLOSIS.

Not Applicable

Completed

• Conditions: -B440 Invasive pulmonary aspergillosis; Invasive pulmonary aspergillosis; B440

• Registration Number: PER-001-99
• 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

a.Prior to inclusion, an informed consent of the patient or legally authorized representative must be obtained. Get a informed assent from underage patients able to understand.

b.Patients can be of any sex. Female patients of childbearing age must have a negative pregnancy test.

c.Patients must have a proven or probable systemic infection caused by Aspergillus species (see Appendix A for diagnostic criteria).

d.Patients should have adequate venous access to allow administration of FK463 and monitoring of safety variables.

Exclusion Criteria

a.Patients who are pregnant or breast-feeding. Women of childbearing age should avoid pregnancy while receiving treatment with the study drug.
b.Patients with any of the following abnormal liver test parameters:
1. AST or ALT> 10 times over the normal limit (ULN)
2. Total bilirubin> 5 times ULN
3. Alkaline Phosphatase> 5 times ULN
c.Patients with allergic bronchopulmonary aspergillosis, aspergillomas, paranasal aspergillosis or otitis externa that have no histopathological evidence of tissue invasion.
d.Patients with a life expectancy considered to be less than 5 days.
e.Patients with a history of allergies, hypersensitivity or any serious reaction to the echinocandin class of antifungals
f.Patients who have participated in this study previously.
g.Patients with a concomitant medical condition, in the opinion of the investigator and / or clinical monitor, whose participation may create an additional unacceptable risk to the patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified