Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Measurement of the pharmacokinetics of LDV\SOF
研究概览
简要总结
This is a prospective, controlled, open-label, pharmacokinetic study. This study aims at studying the PK of ledipasvir, sofosbuvir, and GS-331007 metabolite in HCV infected children with hematological malignancy.
In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir (LDV/SOF) orally, once daily with food.
详细描述
In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir (LDV/SOF) orally, once daily with food, as prescribed by the attending physician.
Twelve eligible HCV-infected patients with hematological malignancy and 12 matching HCV control patients without haematological malignancy or co-morbidities will be enrolled in the study.
At baseline, careful history of the recruited patients including demographic characteristics (age, height, weight, and gender), comorbidities, medication history, familial history, social history, blood transfusion history, time on maintenance chemotherapy, and baseline laboratory tests will be documented. The baseline laboratory tests will include renal function tests (serum creatinine), liver function tests (bilirubin, albumin, AST, and ALT), international normalized ratio (INR), alpha fetoprotein (AFP), complete blood count (CBC), degree of liver fibrosis by Fibroscan, and viral load by PCR.
Followup will be done for all participants at baseline, after 12 weeks of treatment, and after 12 weeks from the end of treatment. A Forth visit will be done after 10 days of treatment for the evaluation of the steady state PK parameters of LDV\SOF in those patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (6 to < 12 years of age and/or weighing 17.5 to < 35 Kg).
- •Chronic HCV genotype 4 infection for at least 6 months without cirrhosis (confirmed by Fibroscan).
- •Naïve patients to previous anti-HCV treatment.
- •Diagnosed with hematological malignancy and on maintenance chemotherapy.
排除标准
- •Known hypersensitivity to any of the study medications.
- •Ongoing treatment with any interacting medications like carbamazepine, fosphenytoin, phenytoin, oxcarbazepine, phenobarbital, and rifampin.
- •History of any comorbid illness that may interfere with the pharmacokinetics of the study drugs or prohibit the compliance with the study protocol such as;
- •Decompensated liver disease as shown by the presence of ascites, encephalopathy, or a history of variceal hemorrhage.
- •The ongoing treatment of other types of cancer or blood disorders.
- •Co-infection with human immunodeficiency virus (HIV), or hepatitis B virus.
- •Renal dysfunction.
- •Active infection that is currently producing symptoms.
研究组 & 干预措施
HCV-infected patients with hematological malignancy
HCV-infected patients with hematological malignancy on maintenance chemotherapy
干预措施: Ledipasvir / Sofosbuvir Oral Product (Drug)
Control HCV-infected patients
Control HCV-infected patients without haematological malignancy or co-morbidities.
干预措施: Ledipasvir / Sofosbuvir Oral Product (Drug)
结局指标
主要结局
Measurement of the pharmacokinetics of LDV\SOF
时间窗: Blood samples will be collected after 10 days of treatment
After 10 days of treatment, the steady state for LDV/SOF will be reached. Serial blood samples (2 mL/sample) will be collected at this time for the determination of LDV/SOF and GS-331007 concentrations from patients using an eight-point plasma schedule. Blood sampling schedule will be as follows (Predose, 0.5,1, 2, 3, 4, 8, and 12h post dose; with predose also serving as t = 24). Any deviations from nominal sampling times will be accurately recorded.
次要结局
- Measurement of the number of participants with sustained virological response (SVR12), 12 weeks after discontinuation of therapy with ledipasvir-sofosbuvir (LDV-SOF).(12 weeks after discontinuation of therapy with ledipasvir-sofosbuvir (LDV\SOF))
研究者
Manal Hamdy El-Sayed
Professor of Pediatrics and Director of the Clinical Research Center
Ain Shams University