An Exploratory, Randomized, Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug Alone in HBeAg Negative Chronic Hepatitis B Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone
研究概览
简要总结
Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. Also it remains unknown if combination of more potent analogues is more beneficial than individual drugs. Thus this study is carried out to determine the efficacy and safety of combination of tenofovir plus telbivudine (two most potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week open labelled, prospective, randomized, multicentric study. The patient will receive either tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the non-responders (ie HBV-DNA > 300 copies/ ml) will be switched to combination arm and will continue receiving tenofovir plus telbivudine for 104 weeks.
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
- •HBeAg negative at screening
- •Documented chronic Hepatitis B
- •Treatment naive
- •Compensated liver disease
排除标准
- •Chronic Hepatitis B with Child Pugh B & C
- •HBeAg positive
- •Decompensated liver disease
研究组 & 干预措施
Tenofovir
干预措施: Tenofovir (Drug)
Telbivudine
干预措施: Telbivudine (Drug)
Tenofovir plus Telbivudine
干预措施: Tenofovir plus Telbivudine (Drug)
结局指标
主要结局
Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone
时间窗: 6 Months and 2 Years
次要结局
- Percentage of patients with reduction in HBsAg concentration by >50%(Baseline and 2 Years)
- Percentage of patients with virological breakthrough(24 weeks)
- Percentage of patients with primary treatment failure(12 weeks)
- Percentage change in serum HBV DNA levels(Baseline and 2 Years)
- Percentage of patients with ALT normalization(Baseline and 2 Years)
- Occurrence of adverse events(2 Years)