Phase IV Study of Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sustained virological response after stopping anti-viral treatment
研究概览
简要总结
The aim of this study is to investigate the off-treatment sustained virological and biochemical response in chronic hepatitis B patients following the guideline by the Asian Pacific Association for the Study of the Liver (APASL) in Korea.
详细描述
In the recommendation by the Asian PAcific Association for the Study of the Liver(APASL), antiviral drug is recommended to stop when HBeAg seroconversion has developed for more than 6 months among HBeAg-positive patietns. For HBeAg-negative patients, the APASL consensus recommended stopping anti-viral treatment when HBV DNA remained undetectable for three separates occasion 6 months apart. Nontheless, approximately 25% to 50% of the patients still develop hepatitis relapse after stopping anti-viral therapy even if these recommendations are followed. In this study, the investigators aimed to investigated the off-treatment sustained response in chronic hepatitis B parients following the stopping anti-viral treatment guideline in Korea.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 20 years old
- •Chronic hepatitis B patients under anti-viral therapy
- •In HBeAg-positive patient; if HBeAg seroconversion with undetectable HBV DNA is documented on two separate occasions at least 6 months
- •In HBeAg-negative patient; if undetectable HBV DNA has been documented on three separate occasions 6 months apart
排除标准
- •Patients who had chronic liver disease due to hemochromatosis, autoimmune hepatitis, drug-induced hepatitis, or thalassemia
- •Patients who suffered from other chronic medical condition
结局指标
主要结局
Sustained virological response after stopping anti-viral treatment
时间窗: Up to 3 years
The proportion of patients with sustained virological response after stopping anti-viral treatment
次要结局
未报告次要终点
研究者
Sang Hoon Ahn
Associate Professor
Yonsei University