Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- sustained virological response 12 weeks post-treatment (SVR12)
研究概览
简要总结
This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases).
详细描述
This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases)
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
- •Age: 18 years to 100 years (adult).
- •Sexes: all
- •Healthy volunteers: no
- •Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
排除标准
- 未提供
结局指标
主要结局
sustained virological response 12 weeks post-treatment (SVR12)
时间窗: 12 weeks after the last dose of study drug
Percentage of participants who achieve sustained virological response 12 weeks post-treatment (SVR12) • Measure: Hepatitis C virus ribonucleic acid (HCV-RNA) levels less than the lower limit of quantification.
次要结局
- virologic failure(Up to 8 weeks while on treatment)
- low baseline viral load and SVR12(Baseline and 12 weeks after the last dose of drug)
- SVR 12 and patients with mild fibrosis(Up to 12 weeks after last dose of study drug)