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

FUJISAWA HEALTH CARE INC,0 个研究点目标入组 0 人开始时间: 1999年8月24日最近更新: 2023年9月4日

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•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.

•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.

发起方

FUJISAWA HEALTH CARE INC,