NCT03820102Unknown不适用
Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With Hepatitis C Viral Infection Treated by Direct Acting Antiviral Drugs
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- SVR12
研究概览
简要总结
- Study Changes in lipid profile and the impact of Insulin resistance on virological response in patients with Hepatitis C viral infection treated by Direct Acting Antiviral agents
- The assessment of serum vitamin D levels in HCV infected patients and predictive value of pre-treatment serum vitamin D level for achieving sustained virological response at 12 weeks post-treatment
详细描述
Patients and methods:
This cross-sectional study will include 100patients of chronic HCV infection who attend El Raghy Assiut university Hospital, either inpatients or outpatients. Chronic HCV infection will be diagnosed based on detectable HCV RNA with anti-HCV Ab in patient with clinical and/or ultrasonographic criteria of chronic liver disease.
Patients will receive treatment to HCV by DAAs and follow up for 12 weeks to confirm sustained virological response
Method:
Patients presenting in this study will be subjected to the following:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HCV will receive DAAs for treatment
排除标准
- •Decompensated liver cirrhosis, hepatocellular carcinoma, history of liver transplant
- •Co-existing liver disease (hepatitis B virus, autoimmune hepatitis, human immunodeficiency virus)
- •Extra-hepatic malignancy except after two years of disease free interval.
- •Patients with diabetes mellitus.
- •Patients with Chronic kidney disease.
- •Pregnancy or in ability to use effective contraception.
- •Patients with history of using lipid lowering therapy
- •relapser or failure of previous HCV treatment
结局指标
主要结局
SVR12
时间窗: 12 week after treatment
sustained virological response 12 week after treatment
次要结局
未报告次要终点
研究者
Mohamed Hassan Abdelgawad
Gastroenterologest and hepatologest, doctor in Assiut Police Hospital
Assiut University
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