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Status unknownNCT00399815Updated Sep 18, 2009

Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C

An observational study in Hepatitis C, Chronic, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-09-18.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Observational

The sponsor has not verified this record recently (last verified Sep 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 75 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Hepatitis C, Chronic

Keywords

  • Chronic viral hepatitis C
  • HCV RNA
  • Fibroscan
  • Fibrotest
  • hepatic elastography by MRI
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 40 is below the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Chronic hepatitis C

Inclusion criteria

  • alteration of liver function tests (ALT, AST)
  • HCV RNA positive

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (estimated)
Biospecimen retention
Samples without dna
06

Study locations

1 of 1 sites recruiting
  • Cliniques Universitaires StLuc, Université catholique de Louvain (UCL)
    Brussels, 1200, Belgium
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00399815
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
First posted
Nov 15, 2006
Start date
Jun 2006
Primary completion
May 2009
Completion
May 2010 (estimated)
Last update
Sep 18, 2009

Study contacts

Yves J Horsmans, M.D., Ph.D.
Contact
horsmans@gaen.ucl.ac.be
32 2 764 28 37
Bernard VanBeers, M.D.,
Contact
vanbeers@rdgn.ucl.ac.be
32 2 764 29 45
Yves J Horsmans, M.D., Ph.D.
study director · Cliniques Universitaires StLuc, Université catholique de Louvain (UCL), Brussels, Belgium

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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