NCT03366610已完成不适用
A Long Term Off-treatment Follow-Up Study to Assess Clinical Outcomes in Chronic Hepatitis C Patients in China Previously Treated With Daclatasvir-Based Regimens
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2017年4月28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
- 199
- 试验地点
- 1
- 主要终点
- Incidence of hepatic disease progression events
研究概览
简要总结
The purpose of this study is to assess long-term outcomes in subjects previously treated with daclatasvir-based therapy for chronic Hepatitis-C (CHC)
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
- •Males or females 18 years of age or older at initiation of prior DCV-based therapy
- •Previously treated with DCV (manufactured by BMS)-based therapy in combination with other HCV direct acting antivirals (DAAs) for at least 8 weeks
- •Must enroll in this study within 12 months of end of treatment of DCV-based therapy or within 6 months of protocol availability at the clinical site for subjects treated in the AI447036 or AI447114 studies
排除标准
- 未提供
结局指标
主要结局
Incidence of hepatic disease progression events
时间窗: up to 5 years
次要结局
- Durability of virologic response(up to 5 years)
- Change in liver stiffness(baseline up to 5 years)
- Number of subjects with HCV sequence variants(baseline up to 5 years)
- Distribution of HCV retreatment patterns(baseline up to 5 years)
研究者
研究点 (1)
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