NCT00230490终止2 期
Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 150
- 主要终点
- - Safety: Clinical examinations of laboratory tests
研究概览
简要总结
Compare the long-term safety of pradefovir to adefovir dipivoxyl
详细描述
- Compare the long-term safety of pradefovir to adefovir dipivoxyl
- Monitor development of resistance
- Evaluate virologic and biochemical response
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who completed 48 weeks of treatment in study RNA200103-201
排除标准
- •Patients who were determined to be treatment failures in study RNA200103-201
- •Patients who experienced a serious adverse event judged to be related to study drug in study RNA200103-201
- •Patients with a serum creatinine greater than 2.0 mg/dl on two consecutive determinations in study RNA200103-201
结局指标
主要结局
- Safety: Clinical examinations of laboratory tests
- Efficacy: Change in viral load over time
次要结局
- - Efficacy: Proportion of patients with undetectable viral load
研究者
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