NCT03247296Unknown不适用
Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- HCC
研究概览
简要总结
To evaluate the early detection of HCC in patients Taking Sofosbuvir and Daclatasvir.
详细描述
Methodology:
Design:
Prospective, randomized study used to detect early incidence of HCC in patients taking Sofosbuvir and Daclatasvir to treat HCV.
Patients will be recruited from the National Hepatology and Tropical Medicine Research Institute (NHTMRI)
Duration of study:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have positive HCV-RNA and taking DAAS to treat it.
- •Both sexes will be included
- •Age above 18 to 75 years old
- •Child Pugh score ( A and B )
排除标准
- •Total serum bilirubin<3 mg/dl
- •Serum albumin > 2.8 g/dl
- •Platelet count< 50000/mm3 IF any of the above criteria is not caused by liver disease, the patient can be included in the study.
- •HCC, except 4 weeks after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI).
- •Extra- hepatic malignancy.
- •Pregnancy or inability to use effective contraception.
- •Inadequately controlled diabetes mellitus (HbA1c>9%).
研究组 & 干预措施
Group A
Patients taking Sofosbuvir and Daclatasvir
干预措施: Sofosbuvir 400 mg, Daclatasvir, Ribavirin (Drug)
Group B
Patients taking Sofosbuvir,Daclatasvir, and Ribavirin
干预措施: Sofosbuvir 400 mg, Daclatasvir, Ribavirin (Drug)
结局指标
主要结局
HCC
时间窗: 24 weeks
occurence of HCC
次要结局
未报告次要终点
研究者
Aya Mohammed Mohammed Essawy
Assistant Lecturer
MTI University
研究点 (1)
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