NCT01457768已完成不适用
A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 570
- 试验地点
- 310
- 主要终点
- Proportion of participants with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimen
研究概览
简要总结
This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead OAV
- •Have failed to achieve an SVR in a previous Gilead-sponsored study, as defined in the original treatment protocol
- •Provide written, informed consent
- •Be willing and able to comply with the visit schedule
排除标准
- •Individuals planning to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry
- •History of clinically significant illness or any other major medical disorder that may interfere with follow-up, assessments or compliance with the protocol
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Proportion of participants with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimen
时间窗: Up to 3 years
次要结局
- Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen(Up to 3 years)
- Average number of DRM loss by treatment regimen(Up to 3 years)
- Liver disease progression(Up to 3 years)
- Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen(Up to 144 weeks)
研究者
研究点 (310)
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