NCT01341743Unknown4 期
A Multi-center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Generic Entecavir Monotherapy or in Combination With Adefovir for Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 360
- 试验地点
- 16
- 主要终点
- proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy
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
- •Male or female aged 18-65 years;
- •Capable of understanding and signing the informed consent. Willing to comply with the study requirements;
- •Serum HBsAg positive and ALT<10ULN at study screening;
- •Patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment;
排除标准
- •History of viral breakthrough or genotypic resistance on previous therapy;
- •History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
- •Patient has a history of hepatocellular carcinoma(HCC) or findings suggestive of possible HCC;
- •Other protocol defined exclusion criteria.
研究组 & 干预措施
A
Active Comparator
oral entecavir 1mg daily for 104 weeks
干预措施: Entecavir (Drug)
B
Active Comparator
oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
干预措施: Entecavir, Adefovir (Drug)
C
Active Comparator
oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks
干预措施: Entecavir, Adefovir (Drug)
结局指标
主要结局
proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104
时间窗: week 104
次要结局
- serum HBV DNA reduction from baseline at week 104(week 104)
- The proportion of subjects with HBeAg loss and seroconversion at week 104(week104)
- The proportion of subject with HBsAg loss and seroconversion at week 104(week104)
- The proportion of subjects with ALT normalization at week 104(week104)
- The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104(week104)
研究者
研究点 (16)
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