Real World Evidence of the Safety and Clinical Practice Use of Maviret in Adolescents Patients Infected With Chronic Hepatitis C Virus (All Case Survey)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 54
- 主要终点
- Number of Participants with Adverse Drug Reactions (ADRs)
研究概览
简要总结
This study will assess the safety and effectiveness of Maviret (Glecaprevir plus Pibrentasvir (GLE/PIB)) in adolescent participants diagnosed with chronic hepatitis C (CHC) in a real world setting across clinical practice in Japan.
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
- •Chronic Hepatitis C Virus (HCV) infection treated in daily practice with Maviret
- •Enrolled after Maviret treatment begins
- •Prior treatment with Maviret
排除标准
- 未提供
结局指标
主要结局
Number of Participants with Adverse Drug Reactions (ADRs)
时间窗: Up to approximately 36 weeks
Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out.
Percentage of Participants with Adverse Drug Reactions (ADRs)
时间窗: Up to approximately 36 weeks
Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out.
Percentage of Participants with Serious Adverse Events (SAEs)
时间窗: Up to approximately 36 weeks
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgement, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent serious adverse events (TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Number of Participants with Serious Adverse Events (SAEs)
时间窗: Up to approximately 36 weeks
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgement, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent serious adverse events (TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
次要结局
- Percentage of participants achieving Sustained Virologic Response 12 (SVR12)(At Week 12)
- Percentage of participants achieving Sustained Virologic Response (SVR)(At 4, 8, 12 and 24 weeks after last dose of Maviret (up to approximately 36 weeks))
- Percentage of Participants with After-Treatment Virologic Failure (Relapse)(Up to approximately 36 weeks)
- Percentage of Participants with On-Treatment Virologic Failure (Breakthrough)(Up to approximately 36 weeks)