Benefits of Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- SVR 12
研究概览
简要总结
The purpose of the study is to determine if statin can affect the clinical outcome of chronic hepatitis C patients receiving Sofosbuvir/Daclatasvir/Ribavirin combination
详细描述
Aim of the work
To determine the benefits of statin use in CHC patients treated with Sofosbuvir/Daclatasvir/Ribavirin through :
Primary Outcome: Assessment of therapeutic SVR12
Seconadry Outcome
- assessment of Chronic hepatitis C(CHC) infection risk on development of metabolic syndrome through assessment of lipid profile , fasting glucose test , HgbA1C and C-reactive protein(CRP).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients age 18 to 70 years old.
- •Easy to treat group: treatment naïve patients with serum HCV RNA positivity by PCR.
- •Clinically stable condition outpatients.
- •Platelet count ≥ 150,000/mm³.
- •Serum albumin ≥ 3.5 g/dl.
- •Total serum bilirubin ≤ 1.2 mg/dl.
排除标准
- •Inadequately controlled diabetes mellitus (HbA1c > 9%) .
- •Total serum bilirubin > 3mg/dl.
- •HCV-HIV co infection.
- •HBV-HCV co infection.
- •Any cause for chronic liver disease other than hepatitis C
- •Uncontrolled hypothyroidism.
- •Hepatocellular carcinoma, except 4 weeks after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI).
- •Extra-hepatic malignancy except after two years of disease-free interval.
- •Child's C cirrhotic patients.
- •Creatinine kinase > 350 u/l
研究组 & 干预措施
Group I
low dose of simvastatin10 mg plus sofosbuvir 400mg / daclatasvir 60 mg daily for 12 weeks.
干预措施: Simvastatin 10mg (Drug)
Group I
low dose of simvastatin10 mg plus sofosbuvir 400mg / daclatasvir 60 mg daily for 12 weeks.
干预措施: sofosbuvir plus daclatasvir (Drug)
Group II
sofosbuvir plus daclatasvir
干预措施: sofosbuvir plus daclatasvir (Drug)
结局指标
主要结局
SVR 12
时间窗: 3 months after end of therapy
sustained virological response 3 months after the end of therapy
次要结局
- Lipid marker(three months)
- Glycemic status marker(three months)
- inflammatory marker(three months)
研究者
Sara Mahmoud Shaheen
Associate Professor, Faculty of pharmacy, Ain Shams University
Ain Shams University