NCT01192854已完成3 期
A Multi-center, Randomized, Double-blind, Positive-control, Phase III Trial of the Efficacy and Safety of Clevudine
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
- 288
- 试验地点
- 1
- 主要终点
- Value of log10 hepatitis B virus (HBV) DNA decreases form baseline.
研究概览
简要总结
Randomized, double blind parallel group, positive control, multi-center trial. Patients will be randomized at 1:1 ratio in group A or group B
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
- 18 Years 至 65 Years（Adult, Older 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
1
Experimental
干预措施: Clevudine (Drug)
2
Active Comparator
干预措施: Adefovir (Drug)
结局指标
主要结局
Value of log10 hepatitis B virus (HBV) DNA decreases form baseline.
时间窗: 48 weeks
Histological response
时间窗: 48 weeks
次要结局
- Percent of patients with hepatitis B virus (HBV) DNA below limit of detection (LOD) at week 48 with polymerase chain reaction (PCR) assay.(48 weeks)
- Percent of patients with normalization of alanine aminotransferase (ALT) at week 48(48 weeks)
研究者
研究点 (1)
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