A Phase 2, Open-label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Subjects Undergoing Cancer Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric participants who are undergoing cancer chemotherapy.
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
- •Aged 12 to <18 years
- •Parent or legal guardian must provide written informed consent
- •Treatment naïve or experienced children with genotype 1 or 4 HCV infection, and are on a maintenance cancer chemotherapy regimen
- •Receiving a protocol-approved maintenance chemotherapy regimen for a hematological malignancy
- •Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
- •Screening laboratory values within defined thresholds
- •No History of solid organ or bone marrow transplantation
- •No history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
LDV/SOF
Participants will receive LDV/SOF 90/400 mg fixed dose combination (FDC) (1x 90/400 mg tablet or 4 x 22.5/100 mg tablets based on swallowability assessment during screening) for 12 weeks.
干预措施: LDV/SOF (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
时间窗: Posttreatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 50 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
时间窗: First dose date up to Week 12
次要结局
- Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
- Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)(Posttreatment Week 24)
- Percentage of Participants With HCV RNA < LLOQ While on Treatment(Weeks 1, 4, 8, and 12)
- HCV RNA Change From Baseline/Day 1(Baseline; Weeks 1, 4, 8, and 12)
- Percentage of Participants With Virologic Failure(Baseline to Posttreatment Week 24)