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Liver Elastography in Patients Undergoing Treatment for Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434470
Recruitment Status : Unknown
Verified February 2018 by Haukeland University Hospital.
Recruitment status was:  Recruiting
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital

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.

Condition or disease
Hepatitis C Virus Infection

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Liver Elastography in Patients Undergoing Treatment for Hepatitis C - a Longitudinal Study
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Elastography [ Time Frame: Baseline ]
    Obtained liver stiffness measurements (kPa) at baseline of participants receiving antiviral treatment.

  2. Patient record [ Time Frame: Baseline ]
    weight and height will be combined to report BMI in kg/m^2 at baseline of participants receiving antiviral treatment.

  3. Biochemical analyses [ Time Frame: Baseline ]
    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.

  4. B-mode evaluation of the liver [ Time Frame: Baseline ]
    Evaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse) at baseline of participants receiving antiviral treatment.


Secondary Outcome Measures :
  1. Elastography [ Time Frame: 3 months ]
    Obtained liver stiffness measurements (kPa) after end treatment (EOT).

  2. Elastography [ Time Frame: 6 months ]
    Obtained liver stiffness measurements (kPa), 3 months after end of treatment (EOT).

  3. Elastography [ Time Frame: 12 months ]
    Obtained liver stiffness measurements (kPa), 1 year after EOT.

  4. B-mode evaluation of the liver [ Time Frame: 3 months ]
    Evaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse) at at end of treatment (EOT).

  5. B-mode evaluation of the liver [ Time Frame: 6 months ]
    Evaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse), 3 months after end treatment (EOT).

  6. B-mode evaluation of the liver [ Time Frame: 12 months ]
    Evaluation of Liver angle (acute/blunt), Steatosis (yes/no), Liver capsule (regular/irregular), Liver parenchyma (normal/coarse), 1 year after EOT.

  7. Patient record [ Time Frame: 3 months ]
    weight and height will be combined to report BMI in kg/m^2 at end of treatment (EOT).

  8. Patient record [ Time Frame: 6 months ]
    weight and height will be combined to report BMI in kg/m^2, 3 months after end treatment (EOT).

  9. Patient record [ Time Frame: 12 months ]
    weight and height will be combined to report BMI in kg/m^2, 1 year after EOT.

  10. Biochemical analyses [ Time Frame: 3 months ]
    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).

  11. Biochemical analyses [ Time Frame: 6 months ]
    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.

  12. Biochemical analyses [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434470


Contacts
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Contact: Anesa Mulabecirovic, MD 004793888212 anesa.mulabecirovic@uib.no
Contact: Roald Havre 004790842938 roald.flesland.havre@helse-bergen.no

Locations
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Norway
University of Bergen, Haukeland University Hospital Recruiting
Bergen, Hordaland, Norway, 5057
Contact: Anesa Mulabecirovic, MD       anesa.mulabecirovic@uib.no   
Contact: Roald Havre, MD,PhD       roald.flesland.havre@helse-bergen.no   
Principal Investigator: Anesa Mulabecirovic, MD, PhD-Cand         
Sub-Investigator: Alexander Rafael Leiva, MD         
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Investigators
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Principal Investigator: Anesa Mulabecirovic University of Bergen
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03434470    
Other Study ID Numbers: 2016/1902
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Haukeland University Hospital:
Ultrasound
Shear wave elastography
SWE
Hepatitis C
HCV
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections