Clinical Evaluation of Valaciclovir Hydrochloride: 256U87 in Patients With Chickenpox - Open Uncontrolled Study.

GlaxoSmithKline0 个研究点目标入组 43 人开始时间: 2005年3月1日最近更新: 2015年4月15日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 43
主要终点: Plasma aciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will assess the safety and efficacy, and the pharmacokinetics of aciclovir and valaciclovir in children with chickenpox following oral administration of valaciclovir, for the purpose of seeking approval of valaciclovir HCl for the treatment of chickenpox.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 1 Year 至 11 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Subjects aged 1 year to less than 12 years with a clinical diagnosis of chickenpox within 48 hours of the onset of the rash.

排除标准

•History of hypersensitivity reactions.
•Impaired hepatic or renal function.
•Gastrointestinal dysfunction.
•Serious underlying disease.
•Weigh over 40kg.
•Vaccinated for chickenpox.

结局指标

主要结局

Plasma aciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.

次要结局

Plasma valaciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

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