A phase 3, multi-center, open label study to evaluate safety and efficacy of AK1820 for treatment of adult Japanese patients with deep mycosis.

ASAHI KASEI PHARMA CORPORATIO0 个研究点目标入组 103 人开始时间: 2018年4月9日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Main Inclusion Criteria
•Patients fulfilling one of the below definitions;
•(1) invasive aspergillosis
•(2) chronic pulmonary aspergillosis
•(3) mucormycosis
•(4) cryptococcosis
•Women with negative pregnancy tests who intend to properly use contraception during the study, or women with no possibility of becoming pregnant.

•Main Exclusion Criteria
•Women who are pregnant or breastfeeding.
•Patients with hypersensitivity to any of the components of the azole class of antifungals or the investigational product.
•Patients at high risk for QT/QTc prolongation, or patients with risk factors for torsades de pointes, or taking concomitant medications known to prolong the QT/QTc interval.
•Patients with a history of short QT syndrome.
•Patients with liver dysfunction at enrollment.
•Patients with moderate to severe kidney dysfunction at enrollment.
•Patients who receive prohibited concomitant drugs.
•Patients with any other fungal infection other than Aspergillus species, Mucorales, or Cryptococcus species.
•Patients who are not expected to survive study duration.
•Patients with an underlying disease, complication or general condition that would complicate safety and efficacy evaluations.
•Patients with a history of taking voriconazole for deep mycosis and showing no response to this treatment.
•Patients taking systemic antifungals who are unable to stop taking these drugs during the study, or who are showing signs of improvement in their symptoms of deep mycosis as a result of these drugs.

发起方

ASAHI KASEI PHARMA CORPORATIO