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临床试验/NCT03434470
NCT03434470Unknown不适用

Liver Elastography in Patients Undergoing Treatment for Hepatitis C - a Longitudinal Study

Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年2月2日最近更新:
适应症

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

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)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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