Liver Elastography in Patients Undergoing Treatment for Hepatitis C

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

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.

Study Overview

• Status: Unknown
• Conditions: Hepatitis C Virus Infection

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Norway
  • Hordaland
    • Bergen, Hordaland, Norway, 5057
      • Recruiting
      • University of Bergen, Haukeland University Hospital
      • Contact: Anesa Mulabecirovic, MD; Email: anesa.mulabecirovic@uib.no
      • Contact: Roald Havre, MD,PhD; Email: roald.flesland.havre@helse-bergen.no
      • Principal Investigator: Anesa Mulabecirovic, MD, PhD-Cand
      • Sub-Investigator: Alexander Rafael Leiva, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elastography	Obtained liver stiffness measurements (kPa) at baseline of participants receiving antiviral treatment.	Baseline
Patient record	weight and height will be combined to report BMI in kg/m^2 at baseline of participants receiving antiviral treatment.	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.	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elastography	Obtained liver stiffness measurements (kPa) after end treatment (EOT).	3 months
Elastography	Obtained liver stiffness measurements (kPa), 3 months after end of treatment (EOT).	6 months
Elastography	Obtained liver stiffness measurements (kPa), 1 year after EOT.	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).	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).	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.	12 months
Patient record	weight and height will be combined to report BMI in kg/m^2 at end of treatment (EOT).	3 months
Patient record	weight and height will be combined to report BMI in kg/m^2, 3 months after end treatment (EOT).	6 months
Patient record	weight and height will be combined to report BMI in kg/m^2, 1 year after EOT.	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).	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.	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.	12 months

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen
• Investigators: Principal Investigator: Anesa Mulabecirovic, University of Bergen

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2018
• Primary Completion (Anticipated): July 30, 2019
• Study Completion (Anticipated): November 30, 2019

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 13, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Ultrasound; HCV; Hepatitis C; Shear wave elastography; SWE
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: 2016/1902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No