Full Text View
Tabular View
No Study Results Posted
Related Studies
Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C
This study is currently recruiting participants.
Verified by Cliniques universitaires Saint-Luc- Université Catholique de Louvain, April 2007
First Received: November 14, 2006   Last Updated: April 19, 2007   History of Changes
Sponsored by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Information provided by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT00399815
  Purpose

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 (elstography 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 wether 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
Hepatitis C, Chronic

Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Estimated Enrollment: 40
Study Start Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • occular metal foreign body
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399815

Contacts
Contact: Yves J Horsmans, M.D., Ph.D. 32 2 764 28 37 horsmans@gaen.ucl.ac.be
Contact: Bernard VanBeers, M.D., 32 2 764 29 45 vanbeers@rdgn.ucl.ac.be

Locations
Belgium
Cliniques Universitaires StLuc, Université catholique de Louvain (UCL) Recruiting
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Study Director: Yves J Horsmans, M.D., Ph.D. Cliniques Universitaires StLuc, Université catholique de Louvain (UCL), Brussels, Belgium
  More Information

No publications provided

Study ID Numbers: ELASTO2
Study First Received: November 14, 2006
Last Updated: April 19, 2007
ClinicalTrials.gov Identifier: NCT00399815     History of Changes
Health Authority: Belgium: Institutional Review Board

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Chronic viral hepatitis C
HCV RNA
Fibroscan
Fibrotest
hepatic elastography by MRI

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatic Fibrosis
Hepatitis, Chronic
Fibrosis
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:
Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Flaviviridae Infections
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on September 11, 2009