Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children From 3 to Less Than 18 Years of Age With GT-1 to -6 Chronic Hepatitis C (CHC) Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) for Daclatasvir
研究概览
简要总结
The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants monoinfected with HCV genotype -1 to -6
- •HCV RNA ≥1,000 IU/mL at Screening
- •Participants who are HCV-treatment naïve or treatment experienced
- •Participants in Cohort 1 must have a body weight ≥ 45kg at Day 1
排除标准
- •Mixed genotype HCV infections
- •Evidence of an ongoing medical condition contributing to chronic liver disease other than HCV
- •Evidence of cirrhosis, either compensated or decompensated
- •Prior exposure to sofosbuvir and/or NS5A inhibitor
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Daclatasvir with Sofosbuvir
Specified dose on specified days for specified duration
干预措施: Daclatasvir (Drug)
Daclatasvir with Sofosbuvir
Specified dose on specified days for specified duration
干预措施: Sofosbuvir (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) for Daclatasvir
时间窗: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir
时间窗: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Apparent Total Body Clearance (CLT/F) for Daclatasvir
时间窗: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir
时间窗: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir
时间窗: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose
次要结局
- Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12(12 weeks after last dose)
- Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis(From the day after first dose to last dose (approximately 12 weeks))
- Number of Participants Experiencing Adverse Events(From first dose to last dose (12 weeks))
- Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis(From day after last dose to end of follow-up period (up to approximately 96 weeks))