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Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00399815
Enrollment
40
Registered
2006-11-15
Start date
2006-06-30
Completion date
2010-05-31
Last updated
2009-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Keywords

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

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.

Interventions

None listed

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Countries

Belgium

Contacts

Primary ContactYves J Horsmans, M.D., Ph.D.
horsmans@gaen.ucl.ac.be32 2 764 28 37
Backup ContactBernard VanBeers, M.D.,
vanbeers@rdgn.ucl.ac.be32 2 764 29 45

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026