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Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C

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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
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Tracking Information
First Submitted Date November 14, 2006
First Posted Date November 15, 2006
Last Update Posted Date September 18, 2009
Study Start Date June 2006
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
liver biopsy serum
Sampling Method Probability Sample
Study Population Chronic hepatitis C
Condition Hepatitis C, Chronic
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November¬†14,¬†2006)
40
Original Enrollment Same as current
Estimated Study Completion Date May 2010
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT00399815
Other Study ID Numbers ELASTO2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof Yves Horsmans, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators Not Provided
Investigators
Study Director: Yves J Horsmans, M.D., Ph.D. Cliniques Universitaires StLuc, Université catholique de Louvain (UCL), Brussels, Belgium
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date September 2009