NCT02727933已完成不适用
Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 1,941 人开始时间: 2015年11月3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
- 1,941
- 试验地点
- 1
- 主要终点
- Frequency of expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities
研究概览
简要总结
The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CHC genotype 1b and compensated liver disease, including cirrhotic patients
- •Eligible for treatment with Daklinza and Sunvepra as indicated in the locally approved prescribing information.
排除标准
- •Off-label use of Daklinza and Sunvepra
- •Patients with a contraindication for the use of Daklinza and Sunvepra as described in the locally approved prescribing information
结局指标
主要结局
Frequency of expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities
时间窗: 6 months to 5 years
次要结局
- Timing of laboratory abnormalities by toxicity grade(6 months to 5 years)
- The sustained virologic response (SVR12) of the combination of Daklinza and Sunvepra (HCV RNA < lower limit of quantification [LLQ] target not detected and detected (HCV RNA < 25 IU/mL)(24 Weeks to 36 Weeks)
- Incidence proportion of AEs leading to discontinuation of study therapy(6 months to 5 years)
- Incidence rate of AEs leading to discontinuation of study therapy(6 months to 5 years)
- Percentage of patients with HCV (Hepatitis C Virus) RNA (Ribonucleic acid)< lower limit of quantification (LLQ) target not detected and detected(4 Weeks to 24 Weeks)
研究者
研究点 (1)
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