Retrospective Analysis of Glecaprevir/Pibrentasvir Safety and Concomitant Medications Through Integrated Real-World Data
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Percentage of Participants Experiencing Adverse Events
研究概览
简要总结
The objective of this study is to assess the safety, tolerability and effectiveness of 8-week Glecaprevir/Pibrentasvir (G/P) in participants taking either prescribed or illicit drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prescribed 8 weeks of Glecaprevir/Pibrentasvir (G/P).
- •Treatment-naïve (for the current infection, participants that may have had prior infections which were resolved with treatment are considered naive for current infection as long as they have not received any treatment for the current infection.)
- •Is concomitantly on one or more prescription medications or illicit drugs.
排除标准
- •Treated with DAAs other than G/P.
- •History of decompensated cirrhosis.
- •Had Hepatitis-B virus (HBV) infection.
- •Had hepatocellular carcinoma (HCC).
研究组 & 干预措施
Glecaprevir/Pibrentasvir
Data from participants prescribed Glecaprevir/pibrentasvir will be collected.
结局指标
主要结局
Percentage of Participants Experiencing Adverse Events
时间窗: Up to approximately 210 days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Percentage of Participants Experiencing On-Treatment Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 5x Upper Limit of Normal (ULN)
时间窗: Up to approximately 210 days
ALT and AST levels will be assessed.
Percentage of Participants Experiencing On-Treatment Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 3x Upper Limit of Normal (ULN) With Total Bilirubin > 2x ULN
时间窗: Up to approximately 210 days
ALT, AST and Bilirubin levels will be assessed.
次要结局
未报告次要终点