An observational study in Hepatitis C Virus Infection, sponsored by Haukeland University Hospital. Status unknown at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-15.
Sponsored by Haukeland University Hospital · Observational
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.
2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.
This study's planned enrollment of 60 is below the median of 245 across 574 observational studies indexed under Hepatitis C.
Browse Hepatitis C studies →Haukeland University Hospital is the lead sponsor of 283 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will be HCV patients (n= 50), who will be invited to join the study consecutively as they have indication to start medical antiviral treatment for 8-, 12-, or 16 week, according to the genotype (1,2,3,4) and fibrosis stage.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Elastography
Obtained liver stiffness measurements (kPa) at baseline of participants receiving antiviral treatment.
Time frame: Baseline
Patient record
weight and height will be combined to report BMI in kg/m\^2 at baseline of participants receiving antiviral treatment.
Time frame: Baseline
Biochemical analyses
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.
Time frame: Baseline
B-mode evaluation of the liver
Evaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse) at baseline of participants receiving antiviral treatment.
Time frame: Baseline
Elastography
Obtained liver stiffness measurements (kPa) after end treatment (EOT).
Time frame: 3 months
Elastography
Obtained liver stiffness measurements (kPa), 3 months after end of treatment (EOT).
Time frame: 6 months
Elastography
Obtained liver stiffness measurements (kPa), 1 year after EOT.
Time frame: 12 months
B-mode evaluation of the liver
Evaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse) at at end of treatment (EOT).
Time frame: 3 months
B-mode evaluation of the liver
Evaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse), 3 months after end treatment (EOT).
Time frame: 6 months
B-mode evaluation of the liver
Evaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse), 1 year after EOT.
Time frame: 12 months
Patient record
weight and height will be combined to report BMI in kg/m\^2 at end of treatment (EOT).
Time frame: 3 months
Patient record
weight and height will be combined to report BMI in kg/m\^2, 3 months after end treatment (EOT).
Time frame: 6 months
Patient record
weight and height will be combined to report BMI in kg/m\^2, 1 year after EOT.
Time frame: 12 months
Biochemical analyses
Transaminases; aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (GGT). Marker panels of liver fibrosis including APRI and FIB-4 index will be calculated, at end of treatment (EOT).
Time frame: 3 months
Biochemical analyses
Transaminases; aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (GGT). Marker panels of liver fibrosis including APRI and FIB-4 index will be calculated, 3 months after EOT.
Time frame: 6 months
Biochemical analyses
Transaminases; aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (GGT). Marker panels of liver fibrosis including APRI and FIB-4 index will be calculated, 1 year after EOT.
Time frame: 12 months
Plan to share: Undecided
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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