A Cross-sectional, Multi-center, Epidemiological Study in Western and Asian Countries in Children and Adolescents With Chronic Hepatitis B
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,640
- 试验地点
- 86
- 主要终点
- Obtain epidemiological data in children and adolescents with chronic hepatitis B that will assist the feasibility and design of studies for the Novartis telbivudine clinical pediatric development program
研究概览
简要总结
The purpose of this study is to collect epidemiological data in children and adolescents with chronic hepatitis B(CHB), in particular data on the prevalence of HBeAg positive disease with associated ALT levels , active HBeAg negative disease and decompensated CHB in the pediatric population. Family history and history of HBV transmission is essential to assess the course of the disease and can be used to determine the best mode of treatment This information will be used to assist with the feasibility and design of studies for the Novartis clinical pediatric development program, as the current epidemiology of ediatric CHB is not accurately known in Western countries or the rest of the world making pediatric studies difficult to plan and conduct. This study forms part of the Novartis Pediatric Investigational Plan, a post marketing approval commitment to the EMEA Pediatric Committee.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Obtain epidemiological data in children and adolescents with chronic hepatitis B that will assist the feasibility and design of studies for the Novartis telbivudine clinical pediatric development program
时间窗: 2 yrs
次要结局
未报告次要终点
