NCT00872196已完成2 期
A Follow-up Study to Assess the Evolution and Persistence of Resistance to ABT-072 After Discontinuation of ABT-072 Therapy in HCV Genotype-1 Infected Subjects Who Participated in Phase 1, 2, or 3 ABT-072 Clinical Studies
AbbVie (prior sponsor, Abbott)1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Analysis of the prevalence of resistance of specific mutations over time will be summarized.
研究概览
简要总结
This is a follow-up study with no treatment and only samples being collected.
详细描述
The purpose of this study is to evaluate the development of specific viral mutations in response to treatment with ABT-072.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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
- •Main Selection Criteria: A subject that has received either ABT-072 or placebo in a prior study involving ABT-072.
排除标准
- •The investigator considers the subject unsuitable for the study for any reasons inclusive of, but not limited to, failure to comply with study procedures in a prior ABT-072 clinical study.
研究组 & 干预措施
1 - Follow-up Study
Other
This is a follow-up study with no treatment and only samples being collected.
干预措施: ABT-072 (Drug)
结局指标
主要结局
Analysis of the prevalence of resistance of specific mutations over time will be summarized.
时间窗: Approximately 48 weeks.
Analysis of the degree of phenotypic resistance (fold change in susceptibility of ABT-072 compared to wild-type virus) will also be summarized.
时间窗: Approximately 48 weeks.
次要结局
- Summary of serious adverse events related to study procedures only.(Approximately 48 weeks.)
研究者
研究点 (1)
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