A Two-Part, Open-Label, Single-Arm Phase 1/2 Study of Safety, Pharmacokinetics, and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Aged 3 to 17 Infected With Genotype 1 Hepatitis C Virus
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 42
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ages 3 to 17 years of age
- •Chronic hepatitis C
- •Hepatitis C virus genotype 1a or b at the Screening Visit
- •Subject is judged to be in good health (besides HCV infection) in the opinion of the investigator.
- •Signed informed consent form (ICF), and where appropriate, signed Assent Form
排除标准
- •History of or prior evidence of a medical condition associated with chronic liver disease other than HCV
- •Body weight <15 kg or >90 kg
- •Prior evidence of hepatic decompensation
- •Contraindications to pegylated interferon/ribavirin (Peg-IFN/RBV)
- •History or other evidence of severe retinopathy or clinically significant ophthalmological disorder
- •History of non-genotype 1 HCV
- •Participation in investigational drug study as described in Study Protocol
- •Use of prohibited drugs within 7 days or 5 half-lives before the first dose of study drug
研究组 & 干预措施
Treatment-Naive or Prior Partial/Null Response
telaprevir + Peginterferon alfa-2b + Ribavirin
干预措施: Ribavirin (Drug)
Treatment-Naive or Prior Partial/Null Response
telaprevir + Peginterferon alfa-2b + Ribavirin
干预措施: Telaprevir (Drug)
Treatment-Naive or Prior Partial/Null Response
telaprevir + Peginterferon alfa-2b + Ribavirin
干预措施: Peginterferon alfa-2b (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to Week 52
AE: any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents administered during the course of the study.
次要结局
- Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)(24 weeks after last planned dose of study drug (up to Week 72))
- Percentage of Participants With Rapid Virologic Response (RVR)(Week 4)
- Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)(12 weeks after last planned dose of study drug (up to Week 60))
- Percentage of Participants With Extended Rapid Virologic Response (eRVR)(Week 4 and Week 12)
- Percentage of Participants With Undetectable HCV RNA at Week 12(Week 12)
- Percentage of Participants With On-treatment Virologic Failure(Baseline up to Week 48)
- Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region(Baseline, On treatment (up to Week 48))
- Maximum Plasma Concentration (Cmax) of Telaprevir(Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7)
- Time to Reach Maximum Plasma Concentration (Tmax) of Telaprevir(Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7)
- Percentage of Participants With Virologic Relapse(12 weeks after planned EOT (up to Week 60))
- Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir(Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7)
- Elimination Half-Life (T1/2) of Telaprevir(Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7)