A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Harvoni Treatment Regimen 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
- 1,081
- 试验地点
- 71
- 主要终点
- Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)
研究概览
简要总结
The primary objective of this post-marketing surveillance study is to collect and assess data related to the safety and effectiveness of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF)) treatment regimen, per the approved Korea prescribing information for Harvoni, in routine clinical practice in Korea and to report the results to the Ministry of Food and Drug Safety (MFDS). Participants will be treated as part of routine practice at Korean healthcare centers by accredited physicians.
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
- 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
- •Adult individuals who have been informed of all pertinent aspects of the study and have voluntarily signed a Personal Information Protection Act (PIPA) consent form; Pediatric individuals who have the individuals' legally authorized representatives sign the PIPA consent form
排除标准
- •Individuals treated with Harvoni outside of the approved prescribing information in Korea
- •Individuals who have a contra-indication to Harvoni
- •Individuals who have a contra-indication to ribavirin
- •Pregnant or breastfeeding women
- •Individuals who have previously been administered Harvoni
- •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
LDV/SOF
Adult Korean participants and pediatric Korean participants aged 12 to <18 years with genotype 1, 2, 4, 5, and 6 chronic HCV infection who are initiating commercial Harvoni regimen
干预措施: LDV/SOF (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)
时间窗: Up to 30 days following treatment
Incidence of adverse events (AEs) and special situation reports (SSRs) occurring during administration of Harvoni regimen or up to 30 days of treatments will be analyzed.
Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
时间窗: Posttreatment Week 12
The sustained virologic response (SVR) rate will be assessed at 12 weeks after completion (or discontinuation) of Harvoni treatment, defined as the proportion of participants with HCV RNA \< lower limit of quantification (LLOQ) from 2 weeks before Posttreatment Week 12 through Posttreatment Week 24 (based on when the participant's actual visit occurs). The treatment will be assessed as "improved/success" when HCV RNA \< LLOQ is achieved from 2 weeks before Posttreatment Week 12 through Posttreatment Week 24.
次要结局
- Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)(Up to Posttreatment Week 12)