The Safety and Efficacy of Ledipasvir/Sofosbuvir in the Treatment of Chronic Hepatitis C Virus Infection in Naïve Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluate the efficacy of Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), in children with treatment-Naïve, chronic HCV infection, genotype 4.
研究概览
简要总结
Chronic hepatitis C virus (HCV) infection represents a crucial health problem in children that greatly influence their quality of life. Many efforts have been directed toward the investment of effective drugs with high safety profiles and with oral administration for better compliance. The development of a new direct-acting antiviral (DAA) made it possible to achieve these goals.
详细描述
The calculated sample size of the study was ....participants at 5% level of significance and 80 % power, using the following formula:
N= (Z1-α/2+Z1-β) 2 σ1* σ2 / δ 2 This study aims to evaluate the safety and efficacy of the combined Sofosbuvir/ Ledipasvir regimen given for 12 weeks in children aged 12-18 years or weighing at least 35 kg with HCV genotype 4 infections.
Patients will receive Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir) taken orally once daily at a fixed time with or without food for 12 weeks. Visits will be arranged at 4, 8, and 12 weeks. Patients will have easy access to the pediatric hepatology unit and the treating physician if any urgent problem happens in between the visits.
The SPSS software version 24, SPSS was used for data processing
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HCV infection (≥ 6 months).
- •Weighing at least 35 kg.
- •Treatment-naïve children with chronic HCV infection without cirrhosis or with compensated cirrhosis.
- •Parent or legal guardian must provide written informed consent.
排除标准
- •Patients with comorbidity of chronic medical illness (decompensated heart disease, severe renal impairment (GFR < 30) or ESRD, uncontrolled DM).
- •Concomitant HBV or HIV infection.
- •Medications (Amiodarone, beta-blockers).
研究组 & 干预措施
HCV without co-morbidities
Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), orally once daily at a fixed time with or without food for 12 weeks
干预措施: Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet (Drug)
HCV with co-morbidities
Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), orally once daily at a fixed time with or without food for 12 weeks
干预措施: Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet (Drug)
结局指标
主要结局
Evaluate the efficacy of Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), in children with treatment-Naïve, chronic HCV infection, genotype 4.
时间窗: At 12 weeks after discontinuation of therapy
Proportion of patients still with negative PCR
次要结局
- Evaluate the safety of Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), in children with treatment-Naïve, chronic HCV infection, genotype 4.(At 12 weeks after discontinuation of therapy)
研究者
Ahmed Noaman
Lecturer
Mansoura University Children Hospital