EUCTR2012-001151-39-Outside-EU/EEA进行中（未招募）不适用
An Open Label, Intravenous to Oral Switch, Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Immunocompromised Adolescents Aged 12 to <17 Years who are at High Risk for Systemic Fungal Infection
Pfizer Inc. 235 East 42nd Street, New York, NY 100170 个研究点目标入组 26 人开始时间: 2012年3月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female from 12 to <17 years of age.
- •Require treatment for the prevention of systemic fungal infection.
- •Expected to develop neutropenia (ANC <500 cells/µL) lasting more than 10 days following chemotherapy.
- •Anticipated to live for more than 3 months.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 26
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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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2 期
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