OPEN-LABEL, NON-COMPARATIVE STUDY OF FK463 IN 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

适应症

试验速览

暂无简介。

•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.

•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.

发起方

FUJISAWA HEALTH CARE INC,