A Phase 3, Multi-center, Open Label Study to Evaluate Safety and Efficacy of AK1820 for Treatment of Adult Japanese Patients With Deep Mycosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Percentage of patients with adverse events between the first administration of investigational product and the end of Follow-up.
研究概览
简要总结
The objective of this study is to investigate the safety and efficacy of administering 372.6 mg of AK1820 (isavuconazonium sulfate) intravenously or orally to adult Japanese patients with deep mycosis. The primary endpoint is safety (percentage of patients with adverse events after starting the study treatment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have the below proven, probable or possible deep mycosis;
- •invasive aspergillosis
- •chronic pulmonary aspergillosis
- •mucormycosis
- •cryptococcosis
- •Female patients must be non-lactating and at no risk for pregnancy.
排除标准
- •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, order 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.
研究组 & 干预措施
AK1820
Participants will receive a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) or orally for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they will reach a treatment endpoint or for a maximum of 84 days.
干预措施: AK1820 (Drug)
Voriconazole
Participants will receive a loading dose of voriconazole, 6 mg/kg every 12 hours IV or 300 mg every 12 hours orally for the first 24 hours, followed by a maintenance dose from Day 2 of 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they will reach a treatment endpoint or for a maximum of 84 days.
干预措施: Voriconazole (Drug)
结局指标
主要结局
Percentage of patients with adverse events between the first administration of investigational product and the end of Follow-up.
时间窗: From the first study drug administration until 28 days after the last dose of study drug (up to approximately Day 112).
次要结局
- Percentage of participants with clinical, radiological and mycological response assessed by the DRC.(Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.)
- Percentage of participants with an overall outcome of success evaluated by the data review committee (DRC).(Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.)
- Percentage of participants with overall outcome, clinical, radiological and mycological response evaluated by investigator.(Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.)
- All-cause mortality.(Through 28 days after the last dose of study drug (up to approximately Day 112).)