JPRN-jRCT2080221537未知2 期
An Open-Label, Intravenous To Oral Switch, Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Children Aged 2 To Less Than 15 Years Who Are At High Risk For Systemic Fungal Infection(A1501096)
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label
入排标准
- 年龄范围
- >= 2age old 至 <= 15age old（—）
- 性别
- All
入选标准
- •Male or female from 2 to <15 years of age.
- •- Require treatment for the prevention of systemic fungal infection.
- •- Expected to develop neutropenia (ANC <500 cells/uL) lasting more than 10 days following chemotherapy.
排除标准
- •- Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia,
- •hypokalemia, hypomagnesemia or hypocalcemia.
- •- Documented bacterial or viral infection not responding to appropriate treatment.
- •- Hypersensitivity to or severe intolerance of azole antifungal agents.
- •- Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.
研究者
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