Comparison of Antiviral Efficacy of Entecavir Monotherapy and Combination Treatment With Poly IC for Chronic Hepatitis B
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Proportion of patients with HBsAg serological response
研究概览
简要总结
The purpose of this study is to investigate antiviral efficacy of the combination treatment with Poly IC and Entecavir and compare with the efficacy of Entecavir mono-therapy for chronic hepatitis B.
详细描述
In this study, the patients with chronic HBV infection will be divided into two groups: HBeAg (+) and HBeAg (-) group. Each group will be divided into two subgroups, which are treated with combination treatment of Entecavir and Poly IC and Entecavir monotherapy respectively. All the patients will be followed up for one year. From this study, the investigators want to study if Poly IC can enhance antiviral efficacy of Entecavir for chronic hepatitis B.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBsAg positive for more than 6 months.
- •Having been treated wit Entecavir and the level of HBV DNA is under 1000 copies/ml.
- •ALT ≤10×ULN， TB <2ULN .
排除标准
- •Previous antiviral treatment for HBV.
- •Co infection of HIV, HCV, HEV, HAV, or HAV.
- •Evidence of hepatic carcinoma.
- •Evidence of autoimmune disease.
- •Evidence of thyroid disease.
- •History of mental sickness.
研究组 & 干预措施
HBeAg(+):Poly IC+Entecavir
45 subjects(HBeAg-positive chronic hepatitis B). Combination therapy will last 24 weeks from 0 week.
Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks. Drug: PolyIC 2mg,im,qod,duration:from 0 week to 24th week
干预措施: Poly IC (Drug)
HBeAg(+):Poly IC+Entecavir
45 subjects(HBeAg-positive chronic hepatitis B). Combination therapy will last 24 weeks from 0 week.
Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks. Drug: PolyIC 2mg,im,qod,duration:from 0 week to 24th week
干预措施: Entecavir (Drug)
HBeAg(+):Entecavir
45 subjects(HBeAg-positive chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.
干预措施: Entecavir (Drug)
HBeAg(-):Poly IC+Entecavir
45 subjects(HBeAg-negative chronic hepatitis B). Combination treatment will last 24 weeks from 0 week.
Drug: Enticavir 0.5mg, P.O.,qd, duration:48 weeks. Drug: PolyIC 2mg,im,qod,duration:from 0 week to 24th week
干预措施: Poly IC (Drug)
HBeAg(-):Poly IC+Entecavir
45 subjects(HBeAg-negative chronic hepatitis B). Combination treatment will last 24 weeks from 0 week.
Drug: Enticavir 0.5mg, P.O.,qd, duration:48 weeks. Drug: PolyIC 2mg,im,qod,duration:from 0 week to 24th week
干预措施: Entecavir (Drug)
HBeAg(-):Entecavir
45 subjects(HBeAg-negative chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.
干预措施: Entecavir (Drug)
结局指标
主要结局
Proportion of patients with HBsAg serological response
时间窗: at week 48 of treatment
The proportion of patients who achieve HBsAg serological response as assessed by the rate of HBsAg seroconversion.
次要结局
- Proportion of patients with HBeAg serological response(at week 48 of treatment)
- Changes in serum HBV DNA levels(at week 4，12，24，36，48，72，96 of treatment)
- Biochemical Response （the serum levels of ALT and AST） Biochemical Response(at week 1，2，4，8，12，16，20，24，36，48，72，96 of treatment)
研究者
Xin Zheng
Professor
Wuhan Union Hospital, China