NCT02640547已完成不适用
Real World Evidence (RWE) of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Poland (HCV RWE PMOS)
AbbVie0 个研究点目标入组 394 人开始时间: 2015年11月26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
- 394
- 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 provide evidence of the effectiveness and obtain patient reported outcomes (PRO) and work productivity data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), +/- dasabuvir (DSV), +/- ribavirin (RBV) in chronic hepatitis C virus infected patients.
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 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).
- •Patients must voluntarily sign and date a patient authorization to use and/or 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 (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.
次要结局
- 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.)
- Percentage of Participants With a Rapid Virological Response at Week 4(Week 4)
- Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24)(24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen))
- Percentage of Participants Achieving Virological Response at End of Treatment(End of treatment (week 12 or 24 depending on the treatment regimen))
- Percentage of Participants With Breakthrough(12 or 24 weeks (depending on the treatment regimen))
- Assigned Treatment Regimen(Baseline)
- Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment (SVR12)(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))
- 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)
- Number of Participants Who Received Concomitant Medications(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen)
- Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen)
- Number of Participants With Comorbidities(Baseline)
- Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies(From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.)
- Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score(Baseline, end of treatment, and at 12 and 24 weeks after end of treatment)
- Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score(Baseline, end of treatment, and at 12 and 24 weeks after end of treatment)
- Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism(Baseline, end of treatment, and at 12 and 24 weeks post treatment)
- Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism(Baseline, end of treatment, and at 12 and 24 weeks after end of treatment)
- Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)(Baseline, end of treatment, and at 12 and 24 weeks after end of treatment)
- Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment(Baseline, end of treatment, and at 12 and 24 weeks after end of treatment)
研究者
相似试验
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 HungaryChronic Hepatitis CNCT02636608AbbVie244
已完成
不适用
Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir (r) - Ombitasvir, + Dasabuvir Without Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis in the Russian FederationChronic Hepatitis CNCT03053180AbbVie60
已完成
不适用
Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)Chronic Hepatitis CNCT02582658AbbVie173
已完成
不适用
Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in RomaniaChronic Hepatitis CNCT02807402AbbVie522
Unknown
不适用
A China RWS to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic SeizureEpilepsyNCT05257915Beijing Children's Hospital600