NCT02582658已完成不适用
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Austria (REAL)
AbbVie0 个研究点目标入组 173 人开始时间: 2015年10月6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
- 173
- 主要终点
- Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
研究概览
简要总结
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin (RBV) in chronic hepatitis C virus (HCV) infected participants in Austria.
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
- •Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype (GT)1 or GT4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label
- •If RBV is co-administered with the ABBVIE REGIMEN, 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 a patient authorization to use and disclose his/her anonymized health data prior to inclusion into the study
- •Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial
排除标准
- 未提供
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
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \< 50 IU/mL 12 weeks after the last actual dose of study drug.
次要结局
- Percentage of Participants With Virological Response at End of Treatment (EoTR)(Up to 24 weeks of treatment)
- Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)(12 weeks after last dose of study drug)
- Percentage of Participants With On-treatment Virologic Failure (Breakthrough)(Up to approximately 24 weeks)
- Percentage of Participants With Post-treatment Relapse(Up to 12 weeks after last dose of study drug)
研究者
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