Liver Elastography in Patients Undergoing Treatment for Hepatitis C

Hepatitis C Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03434470
• Other study ID #: 2016/1902
• Status: Recruiting
• Phase: N/A
• First received: January 24, 2018
• Last updated: February 13, 2018
• Start date: February 2, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: February 2018
• Source: Haukeland University Hospital
• Contact: Anesa Mulabecirovic, MD
• Phone: 004793888212
• Email: anesa.mulabecirovic[@]uib.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection
• Virus Diseases

Locations

Country	Name	City	State
Norway	University of Bergen, Haukeland University Hospital	Bergen	Hordaland

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elastography	Obtained liver stiffness measurements (kPa) at baseline of participants receiving antiviral treatment.	Baseline
Primary	Patient record	weight and height will be combined to report BMI in kg/m^2 at baseline of participants receiving antiviral treatment.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Secondary	Elastography	Obtained liver stiffness measurements (kPa) after end treatment (EOT).	3 months
Secondary	Elastography	Obtained liver stiffness measurements (kPa), 3 months after end of treatment (EOT).	6 months
Secondary	Elastography	Obtained liver stiffness measurements (kPa), 1 year after EOT.	12 months
Secondary	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).	3 months
Secondary	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).	6 months
Secondary	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.	12 months
Secondary	Patient record	weight and height will be combined to report BMI in kg/m^2 at end of treatment (EOT).	3 months
Secondary	Patient record	weight and height will be combined to report BMI in kg/m^2, 3 months after end treatment (EOT).	6 months
Secondary	Patient record	weight and height will be combined to report BMI in kg/m^2, 1 year after EOT.	12 months
Secondary	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).	3 months
Secondary	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.	6 months
Secondary	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.	12 months