Clincosm LogoSign in Get a demo

Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Unknown status
CT.gov ID
NCT00399815
Collaborator
(none)
40
Enrollment
1
Location
47
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Chronic viral hepatitis C is a frequent liver disease. It is associated with variable degree of hepatic fibrosis. To date, liver histology is still regarded as the gold standard to detect, diagnose and quantify liver fibrosis. This requires to perform a liver biopsy. Severe complications are associated to this procedure in 0.01 to 0.1% of cases. Because of this, the repetition of the biopsy to evaluate the progression of the disease or the response to treatment poses ethical questions. Also, liver biopsy only explore a minimal portion of the liver and liver fibrosis, which is not homogeneous, may be under- or over-estimated.

To avoid risks linked to invasive technique and sampling errors associated to liver biopsy, efforts are being made to develop non-invasive technology to detect and quantitate liver fibrosis.

In this study we will perform in patients with chronic hepatitis C, serum tests, fibroscan (elastography of liver parenchyma determined by ultra-sounds), and elastography of liver parenchyma by MRI.

This study will allow

  • to determine whether non-invasive tests effectively measure liver fibrosis

  • to compare each non-invase test with results of liver biopsy

  • to determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis C.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Study Start Date :
    Jun 1, 2006
    Actual Primary Completion Date :
    May 1, 2009
    Anticipated Study Completion Date :
    May 1, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 75 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • alteration of liver function tests (ALT, AST)

      • HCV RNA positive

      Exclusion Criteria:

      • clotting disorder

      • ongoing treatment with anti-coagulant or anti-aggregant

      • advanced or decompensated cirrhosis (Child-Pugh class C)

      • hepatocellular carcinoma

      • other cancer

      • history of surgery for brain aneurysm

      • pace maker or defibrillator

      • ocular metal foreign body

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Cliniques Universitaires StLuc, Université catholique de Louvain (UCL) Brussels Belgium 1200

      Sponsors and Collaborators

      • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

      Investigators

      • Study Director: Yves J Horsmans, M.D., Ph.D., Cliniques Universitaires StLuc, Université catholique de Louvain (UCL), Brussels, Belgium

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00399815
      Other Study ID Numbers:
      • ELASTO2
      First Posted:
      Nov 15, 2006
      Last Update Posted:
      Sep 18, 2009
      Last Verified:
      Sep 1, 2009
      Keywords provided by , ,
      Chronic viral hepatitis C
      HCV RNA
      Fibroscan
      Fibrotest
      hepatic elastography by MRI
      Additional relevant MeSH terms:
      Hepatitis A
      Hepatitis C
      Hepatitis C, Chronic
      Hepatitis

      Study Results

      No Results Posted as of Sep 18, 2009