Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Colombia (outCome)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment
研究概览
简要总结
This is a prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV) receiving the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) with or without ribavirin (RBV). The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label.
This study focused on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods followed physicians' routine clinical practice using a 12-week treatment regimen (four visits plus two interim data collection windows) or a 24-week treatment regimen (four visits plus three interim data collection windows) and is based on the anticipated regular follow-up for patients undergoing treatment for chronic hepatitis C (CHC). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion.
详细描述
This prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV), receiving the interferon-free ABBVIE REGIMEN with or without RBV are offered the opportunity to participate in this study during a routine clinical visit at the participating sites at the discretion of the physician and is made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study.
After written informed consent is obtained, demographics, HCV disease characteristics, co-morbidities, co-medication, treatment details, and laboratory assessments as recorded in the participant's medical records (source documentation) are documented in the electronic case report form (eCRF). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion. No patient identifiable information was captured; a unique participant number was automatically allocated by the web based system once the investigator or designee created a new participant file.
This study focuses on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods follow physicians' routine clinical practice. The observational study period entailed the following data collection schemes:
- 12-week treatment regimen: four visits plus two interim data collection windows
- 24-week treatment regimen: four visits plus three interim data collection windows This schedule was based on the anticipated regular follow-up for patients undergoing treatment for CHC.
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, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) ± 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).
- •Participant 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 Virologic Response at 12 Weeks (SVR12) Post-treatment
时间窗: 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)
SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN \[paritaprevir/ritonavir - ombitasvir ± dasabuvir\] or ribavirin \[RBV\]).
次要结局
- Percentage of Participants With Relapse(12 weeks (i.e. at least 70 days) after the last dose of study drug)
- Percentage of Participants With Relapse at EoT(12 weeks (i.e. at least 70 days) after the last dose of study drug)
- Percentage of Participants With Virologic Response at End of Treatment (EoT)(Up to EoT, maximum of 24 weeks)
- Percentage of Participants Meeting On-treatment Virologic Failure(Up to EoT, maximum of 24 weeks)
- Number of Participants Meeting Premature Study Drug Discontinuation(Up to EoT, maximum of 24 weeks)
- Percentage of Participants With Viral Breakthrough(Up to EoT, maximum of 24 weeks)
- Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria(During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks))
- Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4)(Week 4)
- Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT(24 weeks after EoT (up to 24 weeks))