Efficacy and Safety in Clinical Practice of Ombitasvir/Paritaprevir/ Ritonavir and Dasabuvir Administered for 8 Weeks (3D8) in Treatment-naïve Genotype 1b Hepatitis C Virus Infected Patients: Analysis of Data From Hepa-C Registry.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sustained virological response 12 weeks post-treatment (SVR12)
研究概览
简要总结
The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).
详细描述
HCV chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The introduction of direct-acting antivirals (DAAs) achieve great effectiveness with minimum SAEs and short treatment duration. However, studies evaluating efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir during 8 weeks are limited in real clinical practice. The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
- •Genotype 1b infection
- •Treatment-naïve and non-cirrhotic
排除标准
- •HCV genotype or subtype other than GT1b.
- •Any current or past clinical evidence of cirrhosis.
研究组 & 干预措施
Spanish cohort with HCV treated with DAA
Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks
干预措施: ombitasvir/paritaprevir/ritonavir 8 weeks (Drug)
Spanish cohort with HCV treated with DAA
Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks
干预措施: dasabuvir 8 weeks (Drug)
结局指标
主要结局
Sustained virological response 12 weeks post-treatment (SVR12)
时间窗: 12 weeks after the last dose of study drug
Percentage of participants who achieve sustained virological response 12 weeks post-treatment (SVR12) • Measure: Hepatitis C virus ribonucleic acid (HCV-RNA) levels less than the lower limit of quantification.
次要结局
- Percentage of patients with virologic failure during treatment(Up to 12 weeks after last dose of study drug)
- Mild fibrosis and sustained virological response 12 weeks post-treatment(Up to 12 weeks after last dose of study drug)
- Percentage of participants with low baseline viral load and SVR12 weeks post-treatment(Baseline and 12 weeks after the last dose of drug)