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Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00399815
First Posted: November 15, 2006
Last Update Posted: September 18, 2009
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.
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  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 (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
Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


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

Biospecimen Retention:   Samples Without DNA
liver biopsy serum

Estimated Enrollment: 40
Study Start Date: June 2006
Estimated Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic hepatitis C
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
  • ocular metal foreign body
  Contacts and Locations
Information from the National Library of Medicine

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


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

Responsible Party: Prof Yves Horsmans, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT00399815     History of Changes
Other Study ID Numbers: ELASTO2
First Submitted: November 14, 2006
First Posted: November 15, 2006
Last Update Posted: September 18, 2009
Last Verified: September 2009

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

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