Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Plasma posaconazole concentration monitoring and its pharmacokinetic
研究概览
简要总结
This study is designed to evaluate the safety, efficacy and Population Pharmacokinetics of Oral Posaconazole in Children with leukemia.
详细描述
Posaconazole as a new triazole antifungal agent with broad spectrum coverage, was recommended for prophylaxis of invasive fungal disease in adults. Some studies have demonstrated the relationship between posaconazole plasma concentration and efficacy and few data have been published in children with leukemia.The purpose of this study is to describe the off-label use of posaconazole oral suspensions in children;to figure out the relationship between concentration and clinical outcomes/ adverse events;to identify factors that influence plasma concentration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1、Patients age 2-14 years with acute leukemia (AML, ALL) undergoing chemotherapy and neutropenia expected to last at least 7 days.
- •2、Karnofsky/Lansky score of 60% or greater. 3、defined as alanine transaminase (ALT) <3 x upper limit of normal (ULN),aspartate aminotransferase (AST) <3 x ULN; serum bilirubin and alkaline phosphatase <2 x ULN.
- •4、No other treatment and combination of triazoles antifungals and drugs like vincristine, sirolimus, cyclosporine etc.
- •5、Able to take oral medication or take medication via enteral feeding tube. 6、Ability to give informed consent. 7、No history of anaphylaxis attributed to the azole class of antifungal agents.
排除标准
- •1、Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction.
- •2、Subject is not considered eligible for this clinical research program with posaconazole.
- •3、Use of medications that are known to interact with posaconazole and that may lead to life-threatening side to effects.
研究组 & 干预措施
posaconazole as antifungal prophylaxis
干预措施: posaconazole oral suspensions (Drug)
结局指标
主要结局
Plasma posaconazole concentration monitoring and its pharmacokinetic
时间窗: 1 year
Blood samples for determination of plasma posaconazole concentration will be collected predoses (just prior to a daily dose) on days 3, 7, 14 and 21. Anther concentration (include peak concentraton) will also be collected at least 7days after the first dose.
Number, type and grade of adverse events of posaconazole assessed by CTCAE v4.0
时间窗: 1 year
Number, type and grade of adverse events of posaconazole oral suspensions to children with leukemia assessed by CTCAE v4.0.
次要结局
- Serious Adverse events and drug-related adverse events monitoring(2 years)
研究者
Yang Lihua
Clinical Professor
Zhujiang Hospital