Liver Elastography in Patients Undergoing Treatment for Hepatitis C

• Conditions: Hepatitis C Virus Infection

• Registration Number: NCT03434470
• Lead Sponsor: Haukeland University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-24
• Status Verified: 2018-02
• Study Start: 2018-02-02
• Study First Submitted QC: 2018-02-13
• Last Update Submitted: 2018-02-13
• Study First Posted: 2018-02-15
• Last Update Posted: 2018-02-15
• Primary Completion: 2019-07-30
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diagnosed with HCV
• HCV RNA positive
• Approved for HCV treatment

Exclusion Criteria

• 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Elastography	Baseline	Obtained liver stiffness measurements (kPa) at baseline of participants receiving antiviral treatment.
Patient record	Baseline	weight and height will be combined to report BMI in kg/m\^2 at baseline of participants receiving antiviral treatment.
Biochemical analyses	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	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.

Secondary Outcome Measures

Name	Time	Method
Elastography	12 months	Obtained liver stiffness measurements (kPa), 1 year after EOT.
B-mode evaluation of the liver	12 months	Evaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse), 1 year after EOT.
Patient record	12 months	weight and height will be combined to report BMI in kg/m\^2, 1 year after EOT.
Biochemical analyses	12 months	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.

Trial Locations

Locations (1)

University of Bergen, Haukeland University Hospital; 🇳🇴 Bergen, Hordaland, Norway