NCT01270165Unknown3 期
Antiviral Efficacy of Continuing Lamivudine Plus Adefovir or Switching to Telbivudine Plus Adefovir in HBeAg-positive Lamivudine-refractory Chronic Hepatitis B Patients Who Have Suboptimal Response to Lamivudine Plus Adefovir for at Least 12 Months
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Virologic response
研究概览
简要总结
No study has reported on the comparative effect of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir in HBeAg-positive lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir. The goal of this study is to compare the efficacy of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir directly in patients with lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir for at least 12 months.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBeAg positive
- •lamivudine and adefovir at least 12 months over 6 months lamivudine treatment for YMDD positive patients
- •HBV DNA over 300 copies/ml
排除标准
- •decompensated cirrhosis
- •renal failure
- •prior interferon usage
- •evidence of HCC or prior organ transplantation
结局指标
主要结局
Virologic response
时间窗: 1 year
次要结局
- Safety, virologic breakthrough and biochemical response(1 year)
研究者
研究点 (2)
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