Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in DAA Treatment-Experienced Patients With Chronic Hepatitis C Genotype 1 in Russian Federation (CHOICE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 10
- 主要终点
- Percentage of Participants Achieving Sustained Virological Response (SVR) at Week 12 (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), liver cancer or the need for liver transplant. This study will evaluate how effective glecaprevir/pibrentasvir (GLE/PIB) is in participants with chronic HCV infection. Effectiveness will be assessed as the achievement of sustained virologic response.
GLE/PIB is an approved drug for the treatment of HCV. Participants 12 years or older with chronic HCV infection will be enrolled. This is a prospective (conducted in future) study in therapy of direct-acting antiviral (DAA) treatment-experienced participants with chronic hepatitis C genotype 1. Around 67 participants will be enrolled at multiple sites in Russian Federation.
Participants will receive oral GLE/PIB tablets as prescribed by the physician in accordance with local clinical practice, international guidelines and/or label. Prescription is independent from this study and is decided before providing opportunity to the participate in the study.
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
- •Direct-acting antiviral treatment-experienced participants with confirmed chronic hepatitis C (CHC) genotype 1, receiving combination therapy with the all oral glecaprevir/pibrentasvir (GLE/PIB) regimens according to standard of care, international guidelines and in line with the current local label.
- •Participants can enroll up to 4 weeks after starting treatment
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 Virological Response (SVR) at Week 12 (SVR12)
时间窗: Week 12 after the end of treatment
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) \< 50 IU/ml or lower limit of quantification/detection (LLoQ/D) available at the site at Week 12 after the last actual dose.
次要结局
- Percent of Glecaprevir/Pibrentasvir Dose Taken by Participant Report in Relation to the Prescribed Target Dose(Up to Week 12 after the end of treatment)
- Number of Participants With Co-morbidities and Taking Concomitant Medication(Up to Week 12 after the end of treatment)
- Health Care Resource Utilization (HCRU)(Up to Week 12 after the end of treatment)
- Number of Participants With Adverse Events (AEs)(Up to Week 12 after the end of treatment)
- Percentage of Participants Who Experienced Post-Baseline Shifts in Clinical Laboratory Values(Up to Week 12 after the end of treatment)
- Percentage of Participants Achieving SVR12(Week 12 after the end of treatment)