NCT02615145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 Germany (LIFE-C)
AbbVie0 个研究点目标入组 472 人开始时间: 2015年12月3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
- 472
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR12)
研究概览
简要总结
The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.
This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Germany in a clinical practice patient population.
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 patients with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with 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/or disclose his/her pseudonymized 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
- •Adolescents; people not treated according to label
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response (SVR12)
时间窗: 12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks)
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (\< 50 IU/mL) 12 weeks after the last actual dose of the ABBVIE REGIMEN.
次要结局
- Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)(24 Weeks After EoT (treatment period was 12 or 24 weeks))
- Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken(Up to Week 12 or Week 24)
- Change From Baseline in FACIT-F Scale Over Time(Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT)
- Change From Baseline to EoT in PAM-13 Questionnaire(Baseline, EoT (treatment period was 12 or 24 weeks))
- Change From Baseline Over Time in WPAI: Total Activity Impairment(Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT)
- Percentage of Participants With Virological Response at End of Treatment (EoTR)(EoT, (treatment period was 12 weeks or 24 weeks))
- Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)(Week 4)
- Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)(48 Weeks After EoT (treatment period was 12 or 24 weeks))
- Change From Baseline in PRISM Over Time(Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks))
- Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection(up to post-treatment Week 48 (treatment period was 12 or 24 weeks))
- Number of Participants With On-Treatment Virological Failure or Relapse(Up to post-treatment Week 12 (treatment period was 12 or 24 weeks))
- Percentage of Participants Taking ≥ 1 Co-Medication(up to post-treatment Week 48 (treatment period was 12 or 24 weeks))
- Mean Duration of of ABBVIE REGIMEN and RBV Taken(Up to Week 12 or Week 24)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies(up to 30 days post treatment (treatment period was 12 weeks or 24 weeks))
- Change From Baseline Over Time in WPAI: Total Work Productivity Impairment(Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT)
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