NCT03069001已完成4 期
Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Egyptian Patients With HCV
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Evaluation at end-of-treatment response
研究概览
简要总结
This prospective study was conducted at Ain Shams University Hospital, Internal Medicine, Hepatology and Gastroenterology Department, and Tropical Medicine Department.
To compare the efficacy of the combination of sofosbuvir and simeprevir for 12 weeks with the combination of sofosbuvir and ribavirin for 24 weeks in Egyptian patients with HCV-related Child A cirrhosis.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic HCV infection with a positive HCV RNA level by PCR.
排除标准
- •Total bilirubin > 2 mg/dl.
- •serum albumin < 2.8 g/dl.
- •INR > 1.
- •platelet count < 50000/mm
- •serum creatinine > 2.5 mg/dl.
- •patients presented by ascites or hepatic encephalopathy.
- •patients with evidence of other causes of liver diseases, including hepatitis A, hepatitis B, autoimmune hepatitis, alcoholic liver disease, drug-induced hepatitis, haemochromatosis, Wilson disease or alpha-1 antitrypsin deficiency.
- •patients with any advanced systemic disease.
- •pregnancy or inability to use effective contraception in females.
研究组 & 干预措施
Sofosbuvir-Simeprevir
Active Comparator
- Sofosbuvir 400 mg orally once-daily.
- Simeprevir 150 mg orally once-daily.
- Group A included 50 patients who received sofosbuvir 400 mg orally once-daily plus simeprevir 150 mg orally once-daily for 12 weeks.
干预措施: Sofosbuvir-Simeprevir (Drug)
Sofosbuvir-Ribavirin
Active Comparator
- Sofosbuvir 400 mg orally once-daily.
- Ribavirin orally twice-daily (according to body weight: 1000 mg daily in patients with a body weight of <75 kg and 1200 mg daily in patients with a body weight of ≥75 kg).
- Group B included 40 patients who received sofosbuvir 400 mg orally once-daily plus ribavirin orally twice-daily for 24 weeks.
干预措施: Sofosbuvir-Ribavirin (Drug)
结局指标
主要结局
Evaluation at end-of-treatment response
时间窗: 12 weeks
undetectable HCV-RNA 12 weeks after the completion of therapy by a sensitive HCV-RNA assay
次要结局
未报告次要终点
研究者
Sara Abdelhakam
Assistant Professor
Ain Shams University
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