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UnknownNCT00399815

Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C

Status
Unknown
Phase
Study type
Observational
Enrollment
40 (estimated)
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2006-06-01
Primary completion
2009-05-01
Completion
2010-05-01
First posted
2006-11-15
Last updated
2009-09-18

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT00399815. Inclusion in this directory is not an endorsement.