Study on the Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- HBsAg decrease after 48 weeks treatment
研究概览
简要总结
There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Tenofovir or interferon alfa is the optimal choice right now. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.
详细描述
There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Poor efficacy is defined as hepatitis b virus DNA is still positive and decreases > 2 lg from baseline. Sequential therapy by using tenofovir or interferon alfa is the optimal choice right now. 100 patients with poor antiviral efficacy of entecavir will be recruited in this study. They are randomly divided into tenofovir group or interferon alfa group. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatitis b virus DNA or HBsAg positive for over half a year;
- •Age from 18 to 65;
- •With poor efficacy of entecavir: Hepatitis b virus DNA is still positive at 24 weeks, and decrease > 2 lg from baseline .
- •Not be treated with interferon alfa ever before.
排除标准
- •Other active liver diseases;
- •Cirrhosis, hepatocellular carcinoma or other malignancy;
- •Pregnancy or lactation;
- •Human immunodeficiency virus infection or congenital immune deficiency diseases;
- •Severe diabetes, autoimmune diseases;
- •Other important organ dysfunctions;
- •Patients can not follow-up.
研究组 & 干预措施
Interferon alfa
Patents are treated with interferon alfa 2a 180μg hypodermic injection once per week for 48 weeks. Then, interferon alfa 2a will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be used if HBsAg is positive.
干预措施: Interferon Alfa 2a (Drug)
结局指标
主要结局
HBsAg decrease after 48 weeks treatment
时间窗: 48 weeks
The patients recruited will be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of HBsAg will be tested again. The investigators want to know the rate of patients with HBsAg level that decreases more than 2 lg from baseline.
次要结局
- HBsAg clearance after 48 weeks treatment(48 weeks)
- Undetectable hepatitis b virus DNA after 48 weeks treatment(48 weeks)
研究者
Liang Peng
Professor
Third Affiliated Hospital, Sun Yat-Sen University