Real World EviDEnce of the EffecTIveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents 12 to <18 Years of Age With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation (DETI-2)
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
- 8
- 主要终点
- Overall Percentage of Participants Achieving Sustained Viral Response 12 (SVR12)
研究概览
简要总结
The objective of this study is to assess the effectiveness of the glecaprevir/pibrentasvir (GLE/PIB) regimen in adolescent participants aged 12 to <18 years of age with chronic hepatitis C (CHC) in clinical practice in the Russian Federation. The study also plans to assess effectiveness of GLE/PIB in subpopulations of interest like co-infected hepatitis C virus (HCV)/human immunodeficiency virus (HIV) adolescents, in various HCV genotype/subgenotype, cirrhotic and non-cirrhotic participants, treatment-experienced (prior treatment with pegylated interferon (pegIFN) or IFN, and/or Ribavirin (RBV) and/or sofosbuvir [PRS]) and treatment-naïve, adolescents who use drugs (PWUD) and non-drug users.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of chronic hepatitis C (CHC) with genotypes 1, 2, 3, 4, 5 or 6 with or without compensated cirrhosis
- •Treatment naive or treatment experienced participants
- •Receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines with the current local label
- •Participant and his/her legal representative voluntarily signs and dates an informed consent form
- •Must not be participating or intending to participant in a concurrent interventional therapeutic trial
排除标准
- 未提供
结局指标
主要结局
Overall Percentage of Participants Achieving Sustained Viral Response 12 (SVR12)
时间窗: At Week 12
Defined as HCV RNA \<50 IU/mL or \<lower limit of qualification/detection (LLoQ/D) at the site 12 weeks after the last actual dose of GLE/PIB.
次要结局
- Number of Participants Taking Concomitant Medications(Up to approximately 28 weeks)
- Percentage of Participants Achieving Sustained Viral Response 12 (SVR12) With a Sensitive Polymerase Chain Reaction (PCR) Available in the Clinical Site(At Week 12)
- Number of Participants With Co-morbidities(At Baseline Visit (Week 0))
- Percentage of GLE/PIB Dose Taken by Participants in Relation to the Prescribed Target Dose(Up to approximately 16 weeks)
- Number of Participants with Adverse Events(Up to approximately 28 weeks)
- Average Number of Visits/Touch Points as Part of Health Care Resource Utilization (HCRU)(Up to approximately 28 weeks)