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Liver Elastography in Patients Undergoing Treatment for Hepatitis C

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03434470
Enrollment
60
Registered
2018-02-15
Start date
2018-02-02
Completion date
2019-11-30
Last updated
2018-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus Infection

Keywords

Ultrasound, Shear wave elastography, SWE, Hepatitis C, HCV

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.

Interventions

None listed

Sponsors

University of Bergen
CollaboratorOTHER
Haukeland University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
B-mode evaluation of the liverBaselineEvaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse) at baseline of participants receiving antiviral treatment.
ElastographyBaselineObtained liver stiffness measurements (kPa) at baseline of participants receiving antiviral treatment.
Patient recordBaselineweight and height will be combined to report BMI in kg/m\^2 at baseline of participants receiving antiviral treatment.
Biochemical analysesBaselineTransaminases; 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.

Secondary

MeasureTime frameDescription
Elastography3 monthsObtained liver stiffness measurements (kPa) after end treatment (EOT).
B-mode evaluation of the liver3 monthsEvaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse) at at end of treatment (EOT).
Patient record3 monthsweight and height will be combined to report BMI in kg/m\^2 at end of treatment (EOT).
Biochemical analyses3 monthsTransaminases; 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).

Countries

Norway

Contacts

Primary ContactAnesa Mulabecirovic, MD
anesa.mulabecirovic@uib.no004793888212
Backup ContactRoald Havre
roald.flesland.havre@helse-bergen.no004790842938

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026