NCT00986778撤回4 期
A Comparative Study of Entecavir vs Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Chinese Subjects
Bristol-Myers Squibb0 个研究点开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- The proportion of patients with HBV DNA < 50 IU/mL at W48
研究概览
简要总结
Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I
- •Naïve to nucleoside/nucleotide analogues except for LVD
- •HBV DNA > 17,200 IU/mL
- •Compensated liver function
- •Serum ALT <10 × ULN
排除标准
- •Women who are pregnant or breastfeeding
- •Evidence of decompensated cirrhosis
- •Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
研究组 & 干预措施
Lamivudine plus Adefovir
Active Comparator
干预措施: Lamivudine (Drug)
Lamivudine plus Adefovir
Active Comparator
干预措施: Adefovir (Drug)
Entecavir
Active Comparator
干预措施: Entecavir (Drug)
Entecavir plus Adefovir
Experimental
干预措施: Entecavir (Drug)
Entecavir plus Adefovir
Experimental
干预措施: Adefovir (Drug)
结局指标
主要结局
The proportion of patients with HBV DNA < 50 IU/mL at W48
时间窗: Week 48
次要结局
- Mean reduction of HBV DNA at W 48 & 96(Week 48 and 96)
- The proportion of subjects with ALT normalization at W 48 & 96(Week 48 & Week 96)
- The proportion of patient with HBV DNA < 50 IU/mL at W 96(Week 96)
- The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96(Week 48 & 96)
- Safety(Week 48 and Week 96)
- Resistance(Week 48 & Week 96)
研究者
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