NCT01457755已完成不适用
A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment 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
- 6,625
- 试验地点
- 313
- 主要终点
- Proportion of participants maintaining SVR at Week 144 by treatment regimen
研究概览
简要总结
This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.
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 oral antiviral agent (OAV)
- •Have achieved SVR in a Gilead-sponsored study, as defined in the original treatment protocol
- •Provide written, informed consent
- •Be willing and able to comply with the visit schedule and protocol-mandated procedures
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 maintaining SVR at Week 144 by treatment regimen
时间窗: Week 144
次要结局
- Proportion of participants with detectable HCV RNA due to reemergence of preexisting virus through Week 144 by treatment regimen(Up to 144 weeks)
- Proportion of participants with detectable HCV resistance mutations through Week 144 by treatment regimen(Up to 144 weeks)
- Proportion of participants with detectable HCV RNA due to reinfection through Week 144 by treatment regimen(Up to 144 weeks)
- Liver disease progression(Up to 144 weeks)
- Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen(Up to 144 weeks)
研究者
研究点 (313)
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