Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Determine the efficacy of lamivudine therapy in patients with prior entecavir treatment with undetectable viral load
研究概览
简要总结
Patients with chronic hepatitis B and treated with entecavir for over 6 months (with no previous other antiviral treatment) will be invited to participate in this study. They will be eligible if their liver tests are normal and their viral load is undetectable. Patients will be switched to lamivudine treatment to assess whether lamivudine can maintain adequate suppression of the hepatitis B virus after successful treatment with entecavir. Patients will be monitored closely after switching treatment at 1 months and then every 3 monthly. If there is any evidence of increase in viral load then patients will be given the option of changing back to entecavir.
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
- •Patients with chronic hepatitis B treated with entecavir for 6 months or more
- •Normal ALT
- •Undetectable HBV DNA by Roche Taqman PCR Assay
- •No other previous therapy with nucleoside/nucleotide analogues
排除标准
- •Presence of other liver diseases including hepatitis C co-infection, autoimmune hepatitis , primary biliary cirrhosis, primary sclerosing cholangitis, alcoholic liver disease, and Wilson's disease
- •History of hepatocellular carcinoma
- •History of decompensated liver disease
研究组 & 干预措施
Entecavir
Ongoing entecavir 0.5mg daily
干预措施: Entecavir (Drug)
Lamivudine
Switch to lamivudine 100mg daily
干预措施: Lamivudine (Drug)
结局指标
主要结局
Determine the efficacy of lamivudine therapy in patients with prior entecavir treatment with undetectable viral load
时间窗: 96 weeks
次要结局
- Determine the chance of lamivudine resistance in patients with prior entecavir treatment with undetectable viral load(96 weeks)
研究者
James Yan Yue Fung
Dr
The University of Hong Kong