REAl World Evidence Of The Effectiveness And Clinical Practice Use Of Glecaprevir/Pibrentasvir For 8 Weeks Treatment In Patients With Chronic HepatitiS C GenotYpes 1 to 6 And Liver Cirrhosis In Russian Federation (EASY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 6
- 主要终点
- Percentage Of Participants Achieving Sustained Virologic Response At 12 Weeks (SVR12)
研究概览
简要总结
Hepatitis C Virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver) and liver cancer leaving trial participants with need for liver transplant. The purpose of this study is to see how effective Glecaprevir/Pibrentasvir (GLE/PIB) is in a real world setting of participants with chronic HCV genotypes 1 to 6 and liver cirrhosis who have never received any treatment for HCV.
GLE/PIB is a drug developed for the treatment of HCV infection. This is a prospective (future), observational study in treatment-naive (those who have not received treatment) participants with HCV genotypes 1 to 6 and compensated cirrhosis. All study participants will receive GLE/PIB as prescribed by their study doctor in accordance with approved local label. Pediatric (12 years and older) and adult participants with a diagnosis of HCV genotypes 1 to 6 and compensated cirrhosis will be enrolled in the study in Russian Federation.
Participants will receive GLE/PIB tablets to be taken by mouth daily according to their physicians' prescription. The total duration of the study is 20 weeks, with a treatment period of 8 weeks and a follow up period of 12 weeks.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.
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
- •Treatment-naïve male or female with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with compensated liver cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen for 8 weeks according to standard of care, international guidelines and in line with the current local label.
- •Participants may be enrolled up to 4 weeks after treatment initiation.
排除标准
- •Participating or intending to participate in a concurrent interventional therapeutic trial.
结局指标
主要结局
Percentage Of Participants Achieving Sustained Virologic Response At 12 Weeks (SVR12)
时间窗: At Week 20
SVR12 is defined as Hepatitis C Virus (HCV) RNA \< 50 IU/ml or \< lower limit of quantification/detection (LLoQ/D) available at the site 12 weeks (i.e.,\>=70 days) after the last actual dose.
次要结局
- Number Of Participants Taking Concomitant Medication(At Week 20)
- Number Of Participants Achieving SVR12 After Last Actual Dose Of GLE/PIB At 12 Weeks In Subgroups Of Interest(At Week 20)
- Number Of Participants With Co-morbidities(At Week 20)
- Percentage Of GLE/PIB Dose Taken In Relation To The Prescribed Target Dose(At Week 20)
- Number of Participants With Adverse Events(Baseline (Week 0) To 30 days post last dose)
- Percentage of Participants With Shifts in Clinical Laboratory Values(Baseline (Week 0) to Week 20)
- Number Of Health Care Resource Utilization (HCRU) Over Time Overall And By Subpopulations Of Interest(At Week 20)