Liver Elastography in Patients Undergoing Treatment for Hepatitis C

NCT ID: NCT03434470

Last Updated: 2018-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-02

Study Completion Date

2019-11-30

Brief Summary

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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

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Conditions

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Hepatitis C Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bergen

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anesa Mulabecirovic

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

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University of Bergen, Haukeland University Hospital

Bergen, Hordaland, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Anesa Mulabecirovic, MD

Role: CONTACT

004793888212

Roald Havre

Role: CONTACT

004790842938

Facility Contacts

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Anesa Mulabecirovic, MD

Role: primary

Roald Havre, MD,PhD

Role: backup

References

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Trelsgard AM, Mulabecirovic A, Leiva RA, Nordaas IK, Mjelle AB, Gilja OH, Havre RF. Multiparametric liver assessment in patients successfully treated for hepatitis C: a 4-year follow-up. Scand J Gastroenterol. 2024 Oct;59(10):1184-1191. doi: 10.1080/00365521.2024.2388691. Epub 2024 Sep 1.

Reference Type DERIVED
PMID: 39219192 (View on PubMed)

Other Identifiers

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2016/1902

Identifier Type: -

Identifier Source: org_study_id

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