Measuring Inflammation Cells (CD163 and CD206) With the Purpose of Examining Reduction of Fibrosis in the Liver of Chronic Hepatitis C Patients Following Treatment With the Medication Sofosbuvir
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Changes in the macrophage activation markers sCD163 and sCD206
研究概览
简要总结
The purpose of the study is to investigate how the liver is affected with regard to inflammation and fibrosis during Sofosbuvir based treatment regimes of chronic hepatitis C.
In order to examine how the liver heals, we want to use blood samples to check for the occurrence of special liver inflammation cells (CD163 and CD206). To assess to which extent fibrosis disappear during treatment, we want to examine the liver with FibroScan (a type of ultrasound examination) and also preferably with extraction of a small tissue sample. We want to examine how the liver function as inflammation and scar tissue decrease, especially concerning the liver's ability to produce proteins. Furthermore, we want to examine with a gastroscopy, if the circulation of blood in the liver is improved after successful treatment with the expected result that potential varicose veins in the esophagus vanish.
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
- •Hepatitis C and initiation of sofosbuvir-based direct-acting antiviral treatment
排除标准
- •HIV or Hepatitis B Virus
研究组 & 干预措施
Sofosbuvir
All patients receiving Sofosbuvir based treatment regimes during the study period will be included in the study.
All patients will receive all interventions (galactose elimination capacity test, gastroscopy, fibroscan), except liver biopsy which the patients may decline to participate in without affecting the participation in the rest of the study. If varices are found during the gastroscopy a liver vein catheterization will be performed.
干预措施: Galactose (Drug)
Sofosbuvir
All patients receiving Sofosbuvir based treatment regimes during the study period will be included in the study.
All patients will receive all interventions (galactose elimination capacity test, gastroscopy, fibroscan), except liver biopsy which the patients may decline to participate in without affecting the participation in the rest of the study. If varices are found during the gastroscopy a liver vein catheterization will be performed.
干预措施: Gastroscopy (Procedure)
Sofosbuvir
All patients receiving Sofosbuvir based treatment regimes during the study period will be included in the study.
All patients will receive all interventions (galactose elimination capacity test, gastroscopy, fibroscan), except liver biopsy which the patients may decline to participate in without affecting the participation in the rest of the study. If varices are found during the gastroscopy a liver vein catheterization will be performed.
干预措施: Liver biopsy (Procedure)
Sofosbuvir
All patients receiving Sofosbuvir based treatment regimes during the study period will be included in the study.
All patients will receive all interventions (galactose elimination capacity test, gastroscopy, fibroscan), except liver biopsy which the patients may decline to participate in without affecting the participation in the rest of the study. If varices are found during the gastroscopy a liver vein catheterization will be performed.
干预措施: Fibroscan (Procedure)
Sofosbuvir
All patients receiving Sofosbuvir based treatment regimes during the study period will be included in the study.
All patients will receive all interventions (galactose elimination capacity test, gastroscopy, fibroscan), except liver biopsy which the patients may decline to participate in without affecting the participation in the rest of the study. If varices are found during the gastroscopy a liver vein catheterization will be performed.
干预措施: Liver vein catheterization (Procedure)
Sofosbuvir
All patients receiving Sofosbuvir based treatment regimes during the study period will be included in the study.
All patients will receive all interventions (galactose elimination capacity test, gastroscopy, fibroscan), except liver biopsy which the patients may decline to participate in without affecting the participation in the rest of the study. If varices are found during the gastroscopy a liver vein catheterization will be performed.
干预措施: Sofosbuvir (Drug)
结局指标
主要结局
Changes in the macrophage activation markers sCD163 and sCD206
时间窗: 1 year
次要结局
- Changes in liver fibrosis with fibroscan(1 year)
- Changes in histological liver fibrosis(1 year)
- Changes in clinical status(1 year)
- Changes in hepatic venous pressure(1 year)
- Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test(1 year)