Clinical trial NCT03434470: Liver Elastography in Patients Undergoing Treatment for Hepatitis C
Official title: Liver Elastography in Patients Undergoing Treatment for Hepatitis C - a Longitudinal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C Virus Infection
Keywords: Ultrasound
Shear wave elastography
SWE
Hepatitis C
HCV
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2018-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Elastography
timeFrame: Baseline
measure: Patient record
timeFrame: Baseline
measure: Biochemical analyses
timeFrame: Baseline
measure: B-mode evaluation of the liver
timeFrame: Baseline
Secondary outcomes:
measure: Elastography
timeFrame: 3 months
measure: Elastography
timeFrame: 6 months
measure: Elastography
timeFrame: 12 months
measure: B-mode evaluation of the liver
timeFrame: 3 months
measure: B-mode evaluation of the liver
timeFrame: 6 months
measure: B-mode evaluation of the liver
timeFrame: 12 months
measure: Patient record
timeFrame: 3 months
measure: Patient record
timeFrame: 6 months
measure: Patient record
timeFrame: 12 months
measure: Biochemical analyses
timeFrame: 3 months
measure: Biochemical analyses
timeFrame: 6 months
measure: Biochemical analyses
timeFrame: 12 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen, Haukeland University Hospital
state: Hordaland
Study officials:
affiliation: University of Bergen
name: Anesa Mulabecirovic
role: PRINCIPAL_INVESTIGATOR
References: