The Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence of Treatment Emergent Adverse Events
研究概览
简要总结
This is an open, uncontrolled study of twenty-five chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety & efficacy of combined therapy ledipasvir (LDV) and sofosbuvir (SOF) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. Safety will be measured by checking for adverse effects, while efficacy will be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral nucleic acids in blood samples.
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
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV chronic infection
- •Treatment naive and treatment experienced (previous interferon treatment)
- •No cirrhosis or compensated cirrhosis
排除标准
- •Co-infection with Hepatitis B (HBV)
- •Other associated chronic liver illness
- •Patients with history of hematemesis (non-cirrhotic portal hypertension)
- •Patients with decompensated cirrhosis (as indicated by biopsy, fibroscan)
- •Patients on drugs known to interact unfavorably (Amioidarone, ..)
研究组 & 干预措施
Combined Therapy LDV and SOF
干预措施: Combined therapy LDV and SOF (Drug)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events
时间窗: During the 12 weeks of treatment.
The presence of any adverse effects will be used to characterize this outcome measure.
Sustained Viral Clearance
时间窗: At Week 12 after end of treatment.
HCV RNA qPCR will be used to determine if the target of viral clearance has been established. Detection limit of the kit is 12 IU/ml.
次要结局
未报告次要终点
研究者
Dr. Tawhida Yassin Abdel Ghaffar
Professor
Yassin Abdelghaffar Charity Center for Liver Disease and Research