NCT00916474已完成不适用
EXTEND: A 3-Year, Virology Follow up Study in Subjects Previously Treated With Telaprevir in Select Clinical Studies
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 408
- 试验地点
- 20
- 主要终点
- Proportion of subjects who maintain undetectable HCV RNA over time after achieving an SVR following telaprevir-based treatment
研究概览
简要总结
Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received at least 1 dose of telaprevir-based treatment in 1 of the following clinical studies: VX05-950-104, VX05-950-104EU, VX06-950-106, VX06-950-107, VX07-950-108, VX08-950-111, or VX-950-TiDP24-C216
- •Have baseline HCV viral sequencing data available from previous telaprevir study
排除标准
- •May not be currently participating in the antiviral follow-up period of an ongoing telaprevir trial. (Note: Subjects who have completed the required antiviral follow-up period but are still participating in the collection of patient-reported outcomes data for their previous telaprevir study may be eligible.)
- •For subjects participating in ongoing studies at the time of enrollment, have more than 90 elapsed days between the database lock or unblinding in the previous telaprevir study and Day 1 in this study
研究组 & 干预措施
Cohort A
Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time
干预措施: telaprevir (Drug)
Cohort B
Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time
干预措施: telaprevir (Drug)
结局指标
主要结局
Proportion of subjects who maintain undetectable HCV RNA over time after achieving an SVR following telaprevir-based treatment
时间窗: 3 years
Change in HCV variants with decreased sensitivity to telaprevir over time in subjects failing to achieve an SVR following telaprevir-based treatment
时间窗: 3 years
次要结局
- Change in HCV variants with decreased sensitivity to telaprevir over time in subjects with late relapse(3 years)
研究者
研究点 (20)
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