NCT01721265终止不适用
3-Year, Observational Study to Evaluate the Durability of Sustained Viral Response and the Kinetics of Antiviral-Resistant HCV in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 145
- 主要终点
- Durability of Sustained viral response [SVR]
研究概览
简要总结
All subjects in this study have previously been in an Idenix HCV study and received study drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study will not be enrolled in this study.
In this study, researchers will try to find answers to these questions:
- How much (if any) hepatitis C virus is in your blood after stopping your Idenix study drug?
- Is your hepatitis C virus possibly resistant to treatment with the Idenix study drug or similar drugs?
详细描述
The data obtained from this study will be used to further understand the long-term efficacy of Idenix DAAs used to treat HCV infection and to further understand HCV resistance to Idenix DAAs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained
- •Have participated in an Idenix-sponsored study of an Idenix DAA
- •Received at least 3 consecutive days of DAA treatment in an Idenix-sponsored study
- •Agreed to comply with the visit schedule and laboratory tests
排除标准
- •Treatment with placebo only, in an Idenix sponsored study
- •Antiviral treatment for HCV after participation in an Idenix sponsored study of an Idenix DAA
结局指标
主要结局
Durability of Sustained viral response [SVR]
时间窗: every 3 months
To evaluate the durability of sustained virological response (SVR). Plasma HCV RNA levels will be monitored over time.
次要结局
- Kinetics of resistant variants(every 3 months)
研究者
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