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

Not Applicable

• 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

• Results First Posted: 1900-01-01
• Study Start: 1999-08-24
• Last Update Posted: 4 September 2023

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

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Treatment success is defined as a complete, partial or stable clinical response. A confidence interval (95% bilateral) for the main final objective will be presented together with a summary of the incidence of treatment success. The success of the treatment will be summarized for all patients and by group of patients (de novo or with therapeutic failure due to toxicity).<br>Measure:The success of treatment at the end of therapy<br>Timepoints:at the end of therapy<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Evaluation of fungal infection: the status of the fungal infection will be evaluated at baseline. Patients should have proven or probable evidence that they suffer from a systemic infection due to AspergiUus<br>Measure:Incidence of mycological response to FK463 (persistence and eradication) on day 14, Day 28 and at the end of therapy<br>Timepoints:on day 14, Day 28 and at the end of therapy<br>