NCT03053180已完成不适用
Real World Evidence Study of the Effectiveness of Paritaprevir/r - Ombitasvir, + Dasabuvir Without Ribavirin in Patients With Chronic HCV Gt1b Infection and Compensated Liver Cirrhosis in the RussIan FederaTion- An ObseRvational, MultI-CeNter Study (CITRIN)
AbbVie7 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年3月20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
- 60
- 试验地点
- 7
- 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 prospective, multi-center, observational study is designed to assess the real world effectiveness of paritaprevir/r - ombitasvir with dasabuvir (3DAA [direct-acting antiviral agent] ABBVIE REGIMEN) without ribavirin (RBV) and to describe baseline characteristics of participants with chronic hepatitis C virus (HCV) genotype 1b (GT1b) infection and compensated liver cirrhosis in Russia.
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
- •3DAA ABBVIE REGIMEN will be prescribed by physicians according to the routine clinical practice
- •Treatment-naïve or interferon (IFN)/ribavirin (RBV)-experienced participants with confirmed CHC Gt1b and compensated liver cirrhosis, receiving therapy with the interferon-free 3DAA ABBVIE REGIMEN initiated not earlier than 2 weeks before the enrollment or the initiation is planned not later than 2 weeks after the day of enrollment in accordance to standard of care and in line with the current local label
- •Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial
排除标准
- •Co-administration ribavirin (RBV) with the 3DAA ABBVIE REGIMEN
- •Participants with Child Pugh B and C cirrhosis
- •Participants with a history of prior direct-acting antiviral agent (DAA) therapy
- •Any other contraindications to the administration of 3DAA ABBVIE REGIMEN according to the label
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 dose of study drug (week 24)
SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.
次要结局
- Percentage of Participants Achieving Virological Response at End of Treatment (EoT)(End of treatment, maximum of 12 weeks)
- Percentage of Participants With Relapse(End of treatment (week 12) and up to 12 weeks after the end of treatment.)
- Percentage of Participants With Failure to Suppress(12 weeks)
- Percentage of Participants With Breakthrough(12 weeks)
- Percentage of Participants With Missing SVR12 Data(12 weeks after the last dose of study drug (week 24))
研究者
研究点 (7)
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