Pharmacokinetics and Safety of Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection

Novartis5 个研究点分布在 4 个国家目标入组 76 人开始时间: 2005年7月1日最近更新: 2007年9月26日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 76
试验地点: 5
主要终点: Step A: Single-dose safety and pharmacokinetics

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash. Serious complications can include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is not a standard of care in immunocompetent children, but is recommended whenever a risk of complication exists. This study will evaluate the safety and blood levels of a new formulation of famciclovir in children 1-12 years of age.

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 12 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Male or female children 1-12 years of age
•Clinical or laboratory evidence of varicella zoster infection
•Patients suspected of having varicella zoster infection

排除标准

•Patients unable to swallow
•Concomitant use of probenecid
•Positive pregnancy
•Additional protocol-defined inclusion/exclusion criterial may apply. For detailed information on eligibility, please contact the study center nearest to you (see below), or call the following number 1-862-778-3544 or 1-434-951-3228

结局指标

主要结局

Step A: Single-dose safety and pharmacokinetics

Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days

次要结局

Steps A & B: Acceptability of pediatric formulation by patients

研究者

发起方

Novartis

申办方类型

Industry

研究点 (5)

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