NCT00316719已完成3 期
Phase III Study of Adefovir Dipivoxil Tablets in Patients With Compensated Chronic Hepatitis B -Comparative Study Against Lamivudine-
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 主要终点
- Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52
研究概览
简要总结
This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Adefovir Dipivoxil (ADV)
Experimental
干预措施: ADV group (Drug)
Lamivudine (LAM)
Active Comparator
干预措施: LAM group (Drug)
结局指标
主要结局
Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52
时间窗: Baseline and Week 52
Change from baseline was the difference of the HBV DNA copy numbers (log10) in serum collected by blood draw between baseline and Week 52
次要结局
- Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52(Week 52)
- Time to Onset of HBV DNA Loss (< 400 Copies/mL)(From Baseline to Week 52)
- Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52(Week 52)
- Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52(Week 52)
- Time to Onset of HBeAg Loss(From Baseline to Week 52)
- Time to Onset of HBeAg/Ab Seroconversion(From Baseline to Week 52)
- Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52(Week 52)
- Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52(Week 52)
- Mean Alanine Aminotransferase (ALT) Level at Week 52(Week 52)
- Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52(Week 52)
- Time to Onset of ALT Normalization(From Baseline to Week 52)
- Rate of Emergence of Resistant Virus at Week 52(Week 52)
研究者
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