The Real World Analysis of Drug-Drug Interactions of Grazoprevir/Elbasvir in Treatment of Chronic Hepatitis C Patients in Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- the potential drug drug interaction of elbasvir/grazoprevor
研究概览
简要总结
Co-morbid diseases often present in a substantial proportion of patients with chronic hepatitis C (CHC) and require drugs to treat and control. Grazoprevir/elbavir is metabolized by cytochrome P-450 enzyme of liver. Drug-drug interactions (DDIs) are important issue before commencing direct acting antiviral agents (DAA) treatment for CHC patients. Few studies from Western countries reported that the percentages of DDIs of grazoprevir/elbasvir are limited.In Asia, real-world analysis of DDIs of grazoprevir/elbasvir is lacking and needs to be clarified.
详细描述
This is a multi-center, retrospective study. Five hospitals in Taiwan and 400 patients Patients treated with grazoprevir/elbasvir during August 2017 to July 2018 are candidates of study subjects. All the required study information will be recorded with detailed chart review.
DDI will be evaluated by HEP Drug Interactions (www.hep-druginteractions.org) assessment of comidications: Category 0: Classification not possible due to lack of information; Category 1: No clinical interaction possible; Category 2: May require dose adjustment/closer monitoring; Category 3: Coadministration not recommended or contraindicated.
The assessment of DDI will be evaluated and recorded according to the suggested categories, the number of patients at risk for a clinically relevant DDI, and the ratio of patients with at least one predicted DDI between medication of grazoprevir/elbasvir will be calculated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patients treated with grazoprevir/elbasvir are candidates of study subjects.
排除标准
- 未提供
研究组 & 干预措施
Drug interaction of Elbasvir/Grazoprevir
Patients treated with elbasvir/grazoprevir will be enrolled. DDI will be evaluated.
干预措施: elbasvir/grazoprevir (Drug)
结局指标
主要结局
the potential drug drug interaction of elbasvir/grazoprevor
时间窗: DDI will be assessed before and through the 12 weeks or 16 weeks of elbasvir/grazoprevir treatment
the ratio of patients with at least one predicted DDI will be analyzed.
次要结局
- the comorbid diseases of CHC patients in Taiwan(Comorbid diseases will be assessed before elbasvir/grazoprevir treatment.)
研究者
Pin-Nan Cheng
Associate Professor
National Cheng-Kung University Hospital