NCT00096785已完成3 期
Randomized, Open-Label, Comparative Study to Evaluate Early Viral Load Reductions and Exploratory Viral Kinetics Following Administration of Entecavir or Adefovir in Nucleoside-Naive Adults With Chronic Hepatitis B Infection
Bristol-Myers Squibb2 个研究点 分布在 2 个国家目标入组 69 人开始时间: 2004年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12
研究概览
简要总结
The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.
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
- •Chronic hepatitis B treatment naive
- •Compensated liver disease
排除标准
- 未提供
研究组 & 干预措施
A1
Active Comparator
干预措施: entecavir (Drug)
A2
Active Comparator
干预措施: adefovir (Drug)
结局指标
主要结局
Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12
时间窗: Baseline, Week 12
Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 12, adjusted for baseline (Week 12 - baseline). A negative value = improvement.
次要结局
- Change From Baseline in HBV DNA by PCR Assay at Week 48(Baseline, Week 48)
- Viral Load Undetectable (HBV DNA <300 Copies/mL)(Week 48)
- Alanine Aminotransferase (ALT) Normalization(Week 48)
- HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections(Week 12)
- HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate(Week 12)
- HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus(Week 12)
- HBV DNA Viral Kinetics - Spline Model(Week 12)
- Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths(cumulative through the end of on-treatment observation as available at the time of the Week 48 dataset)
- Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs(Week 48)
研究者
研究点 (2)
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