NCT03868163已完成不适用
Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation
AbbVie9 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2019年2月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 9
- 主要终点
- Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
研究概览
简要总结
This study seeks to assess the effectiveness of Glecaprevir plus Pibrentasvir in participants with chronic hepatitis C in a real-life setting across clinical practice populations in the Russian Federation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment-naïve or - pegIFN (or IFN), and/or Ribavirin (RBV) and/or sofosbuvir (PRS) experienced with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines and in line with the current local label.
- •May be enrolled up to 4 weeks after treatment initiation.
- •Patients must voluntarily sign and date Informed Consent Form prior to inclusion into the study,
- •Patient 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: Up to approximately 28 weeks
SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification/detection (\<LLOQ/D) 12 weeks after the last dose of Glecaprevir plus Pibrentasvir (GLE/PIB).with a sensitive polymerase chain reaction \[PCR\] test with an LLoQ/D of \<50 IU/mL or as described in a validated assay.
次要结局
- Percentage of GLE/PIB Dose Taken(Up to approximately 16 weeks)
- Percentage of Participants Achieving SVR12 by Previous Treatment Experience(Up to approximately 28 weeks)
- Percentage of Participants Taking Concomitant Medications(Up to approximately 28 weeks)
- Number of Health Care Resource Utilization (HCRU)(Up to approximately 28 weeks)
- Percentage of Participants Achieving SVR12 by CHC Genotype(Up to approximately 28 weeks)
- Percentage of Participants Achieving SVR12 by Cirrhosis Status(Up to approximately 28 weeks)
- Percentage of Participants Achieving SVR12 by Patients Who Use Drugs(Up to approximately 28 weeks)
- Percentage of Elderly Participants Achieving SVR12(Up to approximately 28 weeks)
- Percentage of Patients with Commodities(Up to approximately 16 weeks)
- Percentage of Participants Achieving SVR12 by Mono HCV or co-infected HCV/HIV Status(Up to approximately 28 weeks)
研究者
研究点 (9)
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