Early Response to Interferon Combined Short-Term Nucleoside Analogue Therapy in HBeAg(+) Chronic Hepatitis B
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- HBeAg seroconversion rate
研究概览
简要总结
For HBeAg(+) patients, interferon is used for 12 weeks. On 12th week of treatment, If HBV DNA is undetectable (<1000 copies/ml), interferon is continued alone for one year. If HBV DNA is still positive, nucleoside analogue is added for 3 months. After nucleoside analogue is added for 3 months, HBV DNA is tested again. If negative, stop nucleoside analogue and use interferon alone for another 6 months or longer. If HBV DNA is still positive, change to another nucleoside analogue or add another nucleoside analogue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBsAg posive for 6 months
- •HBeAg positive, and HBeAb negative
- •HBV DNA>1.0×E5 copies/ml
- •ALT>80 u/L within 3 months
排除标准
- •pregnant women
- •conbination infection of HCV, HAV, or HEV
- •conbination infection of HIV
- •any contraindication of interferon α
研究组 & 干预措施
1
At the twelfth week of interferon α treatment, HBV DNA is detectable(>1000 copies/ml), or HBeAg is still positive. And nucleoside analogue is added for 12 weeks.
干预措施: interferon α plus nucleoside analogue (Drug)
2
At the twelfth week of interferon α treatment, HBV DNA is detectable (>1000 copies/ml), or HBeAg is still positive. But no nucleoside analogue is added.
干预措施: interferon α (Drug)
3
At the twelfth week of interferon α treatment, HBV DNA is undetectable (<1000 copies/ml), or HBeAg is negative. And interferon is continued for another 9 months.
干预措施: interferon α (Drug)
结局指标
主要结局
HBeAg seroconversion rate
时间窗: 3-6 months
次要结局
- HBV DNA loss rate(3-6 months)
- HBsAg loss rate(3-6 months)