An observational, practice based, open label, prospective, multicenter, post marketingsurveillance to assess safety and efficacy of sofosbuvir as a component of a combinationantiviral treatment regimen for the treatment of patients with chronic hepatitis C (CHC) virusinfection.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- Cipla Ltd
- 入组人数
- 500
- 试验地点
- 10
- 主要终点
- Percentage of patients achieving sustained virological
研究概览
简要总结
The present study is a
· An observational, practice based, open label, prospective, multicenter, post marketing surveillance.
· The study will assess safety and efficacy of sofosbuvir, a HCV (hepatitis C virus) nucleotide analog NS5B polymerase inhibitor, as a component of a combination antiviral treatment regimen for the treatment of patients with CHC infection.
· Eligible patients will be enrolled in the study and will be prescribed Sofosbuvir (manufactured by Cipla Ltd.) 400 mg tablet once daily as a component of a combination antiviral treatment regimen.
· The study population consists of patients with CHC infection
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •A written, signed and dated Data Sharing Informed Consent from all patients/LAR
- •Either gender with age 18 years and above
- •Patients having confirmed diagnosis of chronic hepatitis C virus infection who are either treatment naïve or with prior treatment experience.
排除标准
- •Known hypersensitivity to Sofosbuvir or ribavirin or peginterferon alfa, daclatasvir or any of its components
- •Contraindications to Sofosbuvir or any of the components of the combination regimen
- •Women who are pregnant or may become pregnant and men whose female partners are pregnant
- •Women of child bearing potential who are unwilling to use adequate contraceptive measures unless abstinence is considered adequate in the opinion of the investigator.
- •Any other condition as per the discretion of investigator.
结局指标
主要结局
Percentage of patients achieving sustained virological
时间窗: Percentage of patients achieving sustained virological | response i.e. Maintenance of undetectable HCV RNA levels | at the end of 12 weeks after completion of treatment (SVR12) | · Percentage of patients achieving undetectable HCV RNA | levels at end of 4 weeks of treatment –rapid virological | response (RVR)
response i.e. Maintenance of undetectable HCV RNA levels
时间窗: Percentage of patients achieving sustained virological | response i.e. Maintenance of undetectable HCV RNA levels | at the end of 12 weeks after completion of treatment (SVR12) | · Percentage of patients achieving undetectable HCV RNA | levels at end of 4 weeks of treatment –rapid virological | response (RVR)
at the end of 12 weeks after completion of treatment (SVR12)
时间窗: Percentage of patients achieving sustained virological | response i.e. Maintenance of undetectable HCV RNA levels | at the end of 12 weeks after completion of treatment (SVR12) | · Percentage of patients achieving undetectable HCV RNA | levels at end of 4 weeks of treatment –rapid virological | response (RVR)
· Percentage of patients achieving undetectable HCV RNA
时间窗: Percentage of patients achieving sustained virological | response i.e. Maintenance of undetectable HCV RNA levels | at the end of 12 weeks after completion of treatment (SVR12) | · Percentage of patients achieving undetectable HCV RNA | levels at end of 4 weeks of treatment –rapid virological | response (RVR)
levels at end of 4 weeks of treatment –rapid virological
时间窗: Percentage of patients achieving sustained virological | response i.e. Maintenance of undetectable HCV RNA levels | at the end of 12 weeks after completion of treatment (SVR12) | · Percentage of patients achieving undetectable HCV RNA | levels at end of 4 weeks of treatment –rapid virological | response (RVR)
response (RVR)
时间窗: Percentage of patients achieving sustained virological | response i.e. Maintenance of undetectable HCV RNA levels | at the end of 12 weeks after completion of treatment (SVR12) | · Percentage of patients achieving undetectable HCV RNA | levels at end of 4 weeks of treatment –rapid virological | response (RVR)
次要结局
- Percentage of patients achieving sustained virological response i.e. Maintenance of undetectable(HCV RNA levels at the end of 12 weeks after completion of treatment (SVR12))