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Hepatitis C Virus InfectionNCT03434470

Liver Elastography in Patients Undergoing Treatment for Hepatitis C

An observational study of Hepatitis C Virus Infection, run by Haukeland University Hospital at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C Virus Infection
How many people
60 participants
Where
1 siteNorway
Study dates
2 Feb 2018to 30 Nov 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Diagnosed with HCV
  • HCV RNA positive
  • Approved for HCV treatment

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Anesa Mulabecirovic, MD contact

004793888212

anesa.mulabecirovic@uib.no

Roald Havre contact

004790842938

roald.flesland.havre@helse-bergen.no

Norway1 site, 1 recruiting

  • University of Bergen, Haukeland University Hospital

    Bergen, Hordaland, 5057

    Anesa Mulabecirovic, MD, anesa.mulabecirovic@uib.no

    Roald Havre, MD,PhD, roald.flesland.havre@helse-bergen.no

    Recruiting

Other trials in Norway

About this study

Official title: 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.

Keywords
Ultrasound, Shear wave elastography, SWE, Hepatitis C, HCV
Medical subject headings
Hepatitis C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Elastography

    Obtained liver stiffness measurements (kPa) at baseline of participants receiving antiviral treatment.

    Measured: Baseline

  2. Patient record

    weight and height will be combined to report BMI in kg/m^2 at baseline of participants receiving antiviral treatment.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline

Secondary outcomes (12)

  1. Elastography

    Obtained liver stiffness measurements (kPa) after end treatment (EOT).

    Measured: 3 months

  2. Elastography

    Obtained liver stiffness measurements (kPa), 3 months after end of treatment (EOT).

    Measured: 6 months

  3. Elastography

    Obtained liver stiffness measurements (kPa), 1 year after EOT.

    Measured: 12 months

  4. 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).

    Measured: 3 months

  5. 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).

    Measured: 6 months

  6. 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.

    Measured: 12 months

  7. Patient record

    weight and height will be combined to report BMI in kg/m^2 at end of treatment (EOT).

    Measured: 3 months

  8. Patient record

    weight and height will be combined to report BMI in kg/m^2, 3 months after end treatment (EOT).

    Measured: 6 months

  9. Patient record

    weight and height will be combined to report BMI in kg/m^2, 1 year after EOT.

    Measured: 12 months

  10. 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).

    Measured: 3 months

  11. 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.

    Measured: 6 months

  12. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2018
  2. Study start2 Feb 2018
  3. Primary completion30 Jul 2019 (estimated)
  4. Study completion30 Nov 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03434470
Sponsor's protocol ID
2016/1902
Status last verified
Feb 2018
First submitted
24 Jan 2018
Last updated
15 Feb 2018
Results posted
No
FDA-regulated drug
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39219192

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C Virus Infection, run by Haukeland University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anesa Mulabecirovic, MD (004793888212, anesa.mulabecirovic@uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Elastography (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03434470, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.

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