Nation-wide Hepatitis C Virus (HCV) Registry in Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150,000
- 试验地点
- 1
- 主要终点
- percentage of patients who have successfully eradicated HCV by DAAs
研究概览
简要总结
To determine the treatment efficacy, safety and long-term outcomes of chronic hepatitis C patients receiving directly acting antivirals in Taiwan
详细描述
The National Health Insurance Administration (NHIA) in Taiwan supports the use of antivirals against CHC. Recently, the introduction of directly acting antivirals (DAA) has markedly improved the treatment adherence, efficacy and safety issues in well-designed clinical trials. However, the real world community effectiveness and long-term benefits of DAA for HCV treatments remain to be determined. Since the NHIA in Taiwan has reimbursed the DAA in the treatment of chronic hepatitis C (CHC) patients in the near future, establishment of a well prospectively designed registry policy is demanded in the national level to explore the unmet needs of HCV control in Taiwan. The primary purpose of the study is to establish a nationwide registry of patients undergoing antiviral treatment with DAA regimens for CHC at both academic and community practices. Based on this database, the clinical gaps regarding to treatment guidelines and management of adverse events will be identified. The registry system will be established as a research network and provide sufficient high-quality clinical information for investigators in Taiwan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are treated with DAA and have willingness to participate in this registry.
排除标准
- •Chronic hepatitis C patients who are unwilling to participate in the study and do not provide written informed consent for participation.
结局指标
主要结局
percentage of patients who have successfully eradicated HCV by DAAs
时间窗: 12 months
To determine the treatment efficacy, defined as undetectable HCV RNA 12 weeks after end of therapy (sustained virological response 12 weeks after treatment, SVR12) of chronic hepatitis C patients receiving directly acting antivirals
次要结局
未报告次要终点
