A Post-marketing Surveillance to Assess Safety and Efficacy of Besivo
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Incidence of serious adverse event after this drug administration in general medical practice.
研究概览
简要总结
This study is a post-marketing surveillance of Besivo in participants with chronic hepatitis B.
详细描述
This post-marketing surveillance required by Korea MFDS regulation. The objectives of this study are to monitor adverse events and effectiveness of Besivo.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient diagnosed with chronic hepatitis B.
- •The patient who is first prescribed and administered Besivo.
排除标准
- •The patients who are overreacting to this drug or its components
- •Medium to severe Renal function disorder
- •The patient under 19
- •The Patient who are taboo with L-Carnitine
结局指标
主要结局
Incidence of serious adverse event after this drug administration in general medical practice.
时间窗: 48 weeks
Any serious adverse events occurred after this drug dosing will be recorded. Description of serious adverse event(s) including type of serious adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the serious adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.
Incidence of adverse event after this drug administration in general medical practice.
时间窗: 48weeks
Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.
次要结局
未报告次要终点