NCT02669940已完成不适用
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation - An Observational, Multi-Center Study
AbbVie0 个研究点目标入组 158 人开始时间: 2016年4月15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
- 158
- 主要终点
- Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)
研究概览
简要总结
This study seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir (r) - ombitasvir, ± dasabuvir ± ribavirin (RBV) in participants with chronic hepatitis C in a real life setting across clinical practice populations.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible for observation in this cohort if the following applies:
- •Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label
- •If RBV is co-administered with paritaprevir/r - ombitasvir with or without dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
- •Patients must voluntarily sign and date informed consent prior to inclusion into the study
排除标准
- •Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial
结局指标
主要结局
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)
时间窗: 12 weeks after the last actual dose of study drug
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \< 50 IU/mL 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
次要结局
- SVR12 Non-Response: Percentage of Participants With Breakthrough(12 weeks after the last actual dose of study drug)
- SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data(12 weeks after last actual dose of study drug)
- Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)(24 weeks after last actual dose of study drug)
- SVR12 Non-Response: Percentage of Participants With Relapse(12 weeks after last actual dose of study drug)
- Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse(12 weeks after last actual dose of study drug)
- SVR12 Non-Response: Percentage of Participants With Failure to Suppress(12 weeks after the last actual dose of study drug)
- SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure(12 weeks after last actual dose of study drug)
- Percentage of Participants Achieving Virological Response at End of Treatment(From baseline until end of treatment (12 or 24 weeks after actual first dose))
研究者
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