Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C

Hepatitis C, Chronic Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00399815
• Other study ID #: ELASTO2
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2006
• Last updated: September 17, 2009
• Start date: June 2006
• Est. completion date: May 2010

Study information

• Verified date: September 2009
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Yves J Horsmans, M.D., Ph.D.
• Phone: 32 2 764 28 37
• Email: horsmans[@]gaen.ucl.ac.be
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires StLuc, Université catholique de Louvain (UCL)	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium,