Noninvasive Evaluation of Hepatic Fibrosis in Chronic 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: NCT00399815|
Recruitment Status : Unknown
Verified September 2009 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was: Recruiting
First Posted : November 15, 2006
Last Update Posted : September 18, 2009
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|
|Hepatitis C, Chronic|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Observational Model:||Case Control|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||May 2009|
|Estimated Study Completion Date :||May 2010|
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): NCT00399815
|Contact: Yves J Horsmans, M.D., Ph.D.||32 2 764 28 email@example.com|
|Contact: Bernard VanBeers, M.D.,||32 2 764 29 firstname.lastname@example.org|
|Cliniques Universitaires StLuc, Université catholique de Louvain (UCL)||Recruiting|
|Brussels, Belgium, 1200|
|Study Director:||Yves J Horsmans, M.D., Ph.D.||Cliniques Universitaires StLuc, Université catholique de Louvain (UCL), Brussels, Belgium|