Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,118
- 试验地点
- 156
- 主要终点
- Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)
研究概览
简要总结
The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC) viral infection has been shown to be safe and effective in randomized controlled clinical trials.
This observational study is an effectiveness research examining the regimen of GLE/PIB, used according to local label, under real world conditions in a clinical practice patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are treatment-naïve or treatment-experienced with pegylatedinterferon (pegIFN), or IFN, and/or ribavirin (RBV) and/or sofosbuvir (PRS) with confirmed chronic hepatitis C (CHC), genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral glecaprevir plus pibrentasvir (GLE/PIB) regimen 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
- •Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial.
排除标准
- 未提供
结局指标
主要结局
Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)
时间窗: 12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir
SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification 12 weeks after the last dose of Glecaprevir plus Pibrentasvir
次要结局
- Changes from Baseline in Estimated Glomerular Filtration Rate (eGFR)(Up to 16 weeks)
- Percentage of Glecaprevir plus Pibrentasvir (GLE/PIB) Doses Taken out of that Prescribed(Up to approximately 16 weeks)
- Percentage of Participants with Co-morbidities(Baseline (Day 1))
- Number of Healthcare Resource Utilization (HCRU)(Up to approximately 28 weeks)
- Percentage of Participants Taking Concomitant Medications(Up to approximately 28 weeks)
- Percentage of Participants Using Each Treatment Regimen(Up to 16 weeks)