Randomized, Open-Labeled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B Who Achieved Undetectable HBV DNA
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy
研究概览
简要总结
This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.
详细描述
Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than those of Lamivudine in nucleoside-naïve CHB patients. The switch from Lamivudine to Entecavir in patients who have undetectable hepatitis B virus DNA (HBV DNA < 60 IU/mL) may lead to more prolonged viral suppression to undetectable level by PCR method, compared to patients with continuous lamivudine treatment. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with < HBV DNA 60 IU/mL level and HBeAg positive status.
排除标准
- •Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study.
- •Subjects should have ALT < 10 x ULN, and no evidence of hepatocellular carcinoma.
- •Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
- •Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.
研究组 & 干预措施
A
entecavir 0.5 mg QD
干预措施: Entecavir (Drug)
B
lamivudine 100 mg QD
干预措施: Lamivudine (Drug)
结局指标
主要结局
Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy
时间窗: at Week 96
次要结局
- Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough, Safety assessment(Follow up period)
- Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy(at Week 48)
- Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion(at Week 48 and 96)