Randomized, Open-Labelled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B With Detectable 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 1 mg QD from lamivudine versus maintaining lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine monotherapy.
详细描述
Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than Lamivudine in nucleoside-naïve CHB patients. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL by PCR) may lead to full viral suppression to undetectable level by PCR method. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL) may preclude development of drug resistance. 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 at baseline.
排除标准
- •All subjects will be tested for presence of M204V/I mutations in the YMDD motif at baseline. Subjects with M204V/I mutations in the YMDD motif at baseline are not eligible for the study.
- •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 1.0 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
- Change from baseline in mean HBV DNA(at Week 48 and 96)
- Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion(at Week 48 and 96)
- Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy(at Week 48)
- Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment(Follow up period)
- Percentage number of patients who developed drug resistant mutations while on randomized therapy(at Week 48 and Week 96)
研究者
Sang Hoon Ahn
Associate Professor
Yonsei University