A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Sovaldi in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,033
- 试验地点
- 71
- 主要终点
- Percentage of Participants Experiencing Any Adverse Events (AEs) Occurring During Administration of Sovaldi Regimens or Within 30 Days After Completion (or Discontinuation) of Sovaldi Treatment Regimens
研究概览
简要总结
The objectives of this study are to collect and assess data related to safety and effectiveness of Sovaldi treatment regimens, per the approved prescribing information for Sovaldi, in routine clinical practice and report results to Korean Ministry of Food and Drug Safety (MFDS).
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 12 years and older who are living in Korea
- •Individuals with chronic HCV infection eligible for treatment with Sovaldi as indicated in the approved prescribing information for Sovaldi
- •Individuals who have been informed of all pertinent aspects of the study and have voluntarily signed Personal Information Protection Act (PIPA) consent form; Pediatric individuals who have their legally authorized representatives sign the PIPA consent form
排除标准
- •Individuals treated with Sovaldi outside of the approved prescribing information for Sovaldi in Korea
- •Individuals who have a contra-indication (refer to the Korea prescribing information)
- •Individuals who have a contra-indication to ribavirin or peginterferon alfa or daclatasvir
- •Pregnant or breast feeding women
- •Individuals who have previously been administered Sovaldi
- •Individuals participating in a concurrent HCV clinical trial
- •Individuals planning on leaving the country during the study period
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Sofosbuvir
Adult Korean participants with genotype 1, 2, 3, and 4 chronic HCV infection and pediatric Korean participants aged 12 to <18 years with genotype 2 and 3 chronic HCV infection who are initiating commercial Sovaldi regimens
干预措施: Sofosbuvir (Drug)
结局指标
主要结局
Percentage of Participants Experiencing Any Adverse Events (AEs) Occurring During Administration of Sovaldi Regimens or Within 30 Days After Completion (or Discontinuation) of Sovaldi Treatment Regimens
时间窗: First dose date up to 30 days posttreatment
Proportion of Participants with HCV RNA < Lower Limit of Quantification (LLOQ)
时间窗: 2 weeks before Posttreatment Week 12 through Week 24 Posttreatment
次要结局
- Percentage of Participants Experiencing Any AEs Occurring During Administration of Sovaldi Regimens or Within 12 Weeks After Completion (or Discontinuation) of Sovaldi Treatment Regimens(First dose date up to 12 weeks posttreatment)