NCT02578693已完成不适用
Long Term Follow-up for Subjects With Chronic Hepatitis C Infection Who Received Interferon-based Therapy or Direct-acting Antiviral Agents (DAAs)-Based Therapy
Humanity and Health Research Centre3 个研究点 分布在 2 个国家目标入组 1,210 人开始时间: 2015年5月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,210
- 试验地点
- 3
- 主要终点
- Sustained virological response (SVR)
研究概览
简要总结
The study is designed to provide long term clinical and virologic follow up in subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy. This long term follow up study is observational and no treatment is provided for HCV infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients with chronic hepatitis C treated with interferon-based therapy or direct-acting agents (DAAs)-based regimen;
- •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 time frame;
- •History of clinically significant illness or any other major medical disorder that may interfere with follow up, assessments, or compliance with the protocol.
- •Inability to provide written informed consent.
结局指标
主要结局
Sustained virological response (SVR)
时间窗: 36 months
The primary outcome measure is the occurence (yes or no) of sustained virologic response (SVR), defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) in serum at least 3 months after stopping therapy. Point estimates and confidence intervals will be calculated to describe the frequency of SVR in various patients receiving IFN or DAAs based treatment.
次要结局
- Virological breakthrough(36 months)
- Liver disease progression(Post treatment 10 years)
- Treatment persistence(36 months)
- Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen(Post treatment 5 years)
研究者
研究点 (3)
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