NCT02817594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 The Netherlands (3DUTCH)
AbbVie9 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2016年1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
- 51
- 试验地点
- 9
- 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 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 the Netherlands 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 —（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 participants 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 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).
- •Participants must voluntarily sign and date informed consent prior to inclusion into the study
排除标准
- •Patients participating or intending to participate in a concurrent interventional therapeutic trial.
- •Unable to complete the questionnaires due to cognitive impairment or lack of any kind of cognitive competence, as to be judged by the healthcare professional who is treating the patient.
- •Unable to complete the questionnaires due to language incompetence.
- •Unable to voluntarily sign and date the informed consent.
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 or 36 depending on the treatment regimen)
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.
次要结局
- Percentage of Participants Achieving Virological Response at End of Treatment(End of treatment (week 12 or 24 depending on the treatment regimen))
- Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
- Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.)
- Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen)
- Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.)
- Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies(From first dose of study drug through 30 days after last dose (16 weeks).)
- Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
- Percentage of Participants With Breakthrough(12 or 24 weeks (depending on the treatment regimen))
- Percentage of Participants With Relapse(End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.)
- Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
- Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment(12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen))
- Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment(12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen))
研究者
研究点 (9)
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