Long-term Hepatic and Extra-hepatic Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Interferon-free Treatment (LONGHEAD Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 26
- 主要终点
- Number of participants with liver-related morbidity development during 5-year follow-up period after sofosbuvir-based treatment
研究概览
简要总结
Primary Objective:
To evaluate the long-term outcomes including liver related morbidity, mortality and hepatocellular carcinoma (HCC) development as compared to those of historical control with interferon(IFN)-based treatment.
Secondary Objective:
- To access liver fibrosis progression/regression in CHC patients after sofosbuvir-based treatment.
- To investigate the long-term outcomes of extrahepatic manifestations of the sofosbuvir-based treated cohort as compared to their pretreatment status.
详细描述
Primary Endpoint:
To evaluate the long-term event-free effect after sofosbuvir-based therapy, in terms of free of major liver events (including HCC, decompensation with ascites, variceal bleeding, hepatic encephalopathy, and liver-related mortality) in CHC patients.
Secondary Endpoints:
- To evaluate hepatic fibrosis progression or regression in CHC patients after sofosbuvir-based therapy.
- To evaluate the durability of sustained viral response (SVR) in patients achieving SVR after sofosbuvir-based therapy.
- To evaluate long-term effect of sofosbuvir-based therapy on the extra-hepatic manifestations of the cohort. The items include mixed cryoglobulinemia, chronic kidney diseases, insulin resistance, diabetic status, cardiovascular events and dyslipidemia.
- To evaluate long-term effect of sofosbuvir-based therapy on quality of life on the cohort.
Study Design Prospective, longitudinal observational 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of participants with liver-related morbidity development during 5-year follow-up period after sofosbuvir-based treatment
时间窗: 6 years
Number of participants with liver-related morbidity during 5-year follow-up period after sofosbuvir-based treatment, including liver fibrosis progression and decompensation
Number of participants with liver-related mortality development during 5-year follow-up period after sofosbuvir-based treatment
时间窗: 6 years
Number of participants with liver-related mortality assessed by death due to HCC and/or liver decompensation
Number of participants with hepatocellular carcinoma (HCC) development during 5-year follow-up period after sofosbuvir-based treatment
时间窗: 6 years
Number of participants with HCC assessed by histocytology or positive dynamic image plus alpha fetoprotein (AFP) \> 400 ng/ml
次要结局
- Life quality(6 years)
- Cryoglobulinemia(6 years)
- Diabetes mellitus (DM)(6 years)
- Insulin resistance(6 years)
- Lipid profiles(6 years)
- Renal disease(6 years)