NCT02526641已完成不适用
New AbbVie Direct Acting Antiviral (DAA) Treatment of Chronic Hepatitis C Infection - Effects on the Macrophage Activation Marker Soluble CD163, Portal Hypertension, and Metabolic Liver Function
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 12 weeks
研究概览
简要总结
Investigation of the effects of the new Abbvie direct acting anti-viral (DAA) treatment of chronic viral hepatitis C infection on the macrophage specific activation marker soluble CD163, portal hypertension determined by the hepatic venous pressure gradient (HVPG), and metabolic liver function determined by the galactose elimination capacity (GEC) test and the functional hepatic nitrogen clearance (FHNC).
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis C genotype 1 or 4 patients initiating the new AbbVie treatment (paritaprevir, ritonavir, ombitasvir og dasabuvir sammen med ribavirin)
- •Child-Pugh A liver cirrhosis
排除标准
- •Severe liver dysfunction - Child-Pugh klasse B-C
- •Life expectancy less than 6 months
- •planned liver transplantation or TIPS procedure within 6 months
- •non-compliance to treatment or study procedures
- •allergy to the DAA drugs used (paritaprevir, ritonavir, ombitasvir, dasabuvir, and ribavirin)
- •pregnancy or expected pregnancy during the study (anti-conception has to be used)
- •breast feeding
- •portal vein thrombosis
- •liver cancer or other malignancies
- •alcohol consumption
结局指标
主要结局
Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 12 weeks
时间窗: 12 weeks
Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 1 year
时间窗: 1 year
次要结局
- Changes in the levels of the macrophage specific activation marker sCD163(Before, during and after treatment - 60 weeks)
- Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test(After 12 weeks treatment)
- Changes in the functional hepatic nitrogen clearance (FHNC)(After 12 weeks treatment)
研究者
研究点 (1)
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