Liver Elastography in Patients Undergoing Treatment for Hepatitis C - a Longitudinal Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Elastography
研究概览
简要总结
According to the guidelines for treating hepatitis C livers stiffness (LS) measurement is equivalent to liver biopsy to prove grade-2 fibrosis or more by Metavir-score. Also flares of inflammation in other viral hepatitis (B) have been reported to increase the elastography measurements. There are very few reports so far on longitudinal data in a treatment cohort. In this study investigators will follow patients who undergo active treatment for hepatitis C virus (HCV). Investigators will collect longitudinal data of liver elastography and compare this to the current status of liver inflammation by blood samples. This may be important in order to know if transcutaneous US with elastography can be used as a tool to monitor active inflammation in liver disease and to quantify how much the inflammatory component contribute to LS and finally if it is possible to reverse not only inflammation but also liver fibrosis by treating viral hepatitis. Our aim is to assess shear wave elastography (SWE) and investigate if the method can be used, not only to define the indication for treatment through LS measurements, but also if LS due to inflammation and fibrosis may be reversible in treated patients. To investigate what role frequency of measurement obtains in follow up of patients with HCV play.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with HCV
- •HCV RNA positive
- •Approved for HCV treatment
排除标准
- •Excessive alcohol use
- •Pregnancy
- •information of other cause of chronic liver disease (autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), Alpha-1-antitrypsin deficiency).
结局指标
主要结局
Elastography
时间窗: Baseline
Obtained liver stiffness measurements (kPa) at baseline of participants receiving antiviral treatment.
Patient record
时间窗: Baseline
weight and height will be combined to report BMI in kg/m\^2 at baseline of participants receiving antiviral treatment.
Biochemical analyses
时间窗: Baseline
Transaminases; aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (GGT). Marker panels of liver fibrosis including AST to Platelet Ratio Index (APRI) and Fibrosis-4 index (FIB-4)will be calculated, at baseline of participants receiving antiviral treatment.
B-mode evaluation of the liver
时间窗: Baseline
Evaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse) at baseline of participants receiving antiviral treatment.
次要结局
- Elastography(12 months)
- B-mode evaluation of the liver(12 months)
- Patient record(12 months)
- Biochemical analyses(12 months)
