Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- SVR12
研究概览
简要总结
Randomized, open-label study in treatment naïve and treatment experienced, adolescence to determine the efficacy of Sofosbuvir 400mg/ledipasvir 90mg in treatment naïve and treatment-experienced adolescence. Hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12)
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent.
- •12-18 years
- •HCV RNA ≥ 104 IU/mL at screening.
- •Confirmed chronic HCV infection as documented by either:
- •a. a positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or
- •Screening ECG without clinically significant abnormalities.
- •Patients must have the following laboratory parameters at screening:
- •ALT (Alanine transaminase) ≤ 10 x the upper limit of normal (ULN)
- •AST (Aspartate Aminotransferase) ≤ 10 x ULN
- •Hemoglobin ≥ 12 g/dL for male, ≥ 11 g/dL for female patients
- •Platelets > 50,000 cells/mm3
- •INR (international normalized ratio) ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
- •Albumin ≥ 3 g/dL
- •HbA1c ≤ 10%
- •Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation
- •Patient has not been treated with any investigational drug or device within 30 days of the screening visit.
排除标准
- •Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis).
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
- •History of solid organ transplantation.
- •Current or prior history of clinical hepatic decompensation (eg, ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome).
- •History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
- •History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug.
- •History of significant pulmonary disease, significant cardiac disease or porphyria.
- •History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
- •Donation or loss of more than 400 mL blood within 2 months prior to Baseline/Day
- •Known hypersensitivity to the study investigational medicinal product, the metabolites, or formulation excipients.
研究组 & 干预措施
Arm 1
Treatment-naïve is defined as having never received treatment for HCV with any interferon (IFN), ribavirin , or other approved or experimental HCV specific direct acting antivirals.
干预措施: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) (Drug)
Arm 2
Treatment-experienced is defined as:
- IFN Intolerant
- Non-response
- Relapse/Breakthrough
干预措施: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) (Drug)
Short Track
Treatment-naïve or Treatment-experienced who achived very rapid virological responce - Negative HCV PCR after treatment with (Sofosbuvir 400mg/Ledipasvir 90mg) for 1 week
干预措施: 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) (Drug)
结局指标
主要结局
SVR12
时间窗: 12 weeks after discontinuation of therapy
sustained viral response 12 weeks after discontinuation of therapy (SVR12)
次要结局
- SVR4(4 weeks after discontinuation of therapy)