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Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease (PVTE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01241227
First Posted: November 16, 2010
Last Update Posted: November 16, 2010
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:
Association HGE CHU Bordeaux Sud
October 22, 2010
November 16, 2010
November 16, 2010
April 2003
Not Provided
Overall survival [ Time Frame: 3 months ]
Same as current
No Changes Posted
  • Survival without liver complications [ Time Frame: 3 months ]
  • Survival without liver transplantation [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
 
Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease
Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease. A Prospective Follow-up of 4,935 Person-years
The aim of this prospective study was to compare the 5-year prognostic value of transient elastography (TE), FibroTest (FT), APRI , FIB-4, Lok, and Child-Pugh scores for predicting survival and complications of cirrhosis in patients with chronic liver diseases.
A total of 1616 patients with chronic hepatitis C was included. At 5 years, 79 patients were dead (39 liver-related deaths) and 16 patients had liver transplantation. Overall survival was 91.7% and survival without liver-related death 94.4%. Survival was significantly decreased in patients diagnosed with severe fibrosis, whatever the non-invasive method used. All these methods were able to predict a shorter survival in this large population. Patients had their prognosis decreased as liver stiffness increased. By multivariate analysis, only FibroTest > 0.74 (OR 4.41, 95%CI 1.62-12.01, p=0.004) was associated with overall survival, and liver stiffness > 9.5 kPa (OR 4.71, 95%CI 1.06-21.01, p=0.04) associated with liver-related death.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
We included all consecutive patients with an age over eighteen and a chronic hepatitis C of any severity. The determination of chronic hepatitis C was made using standard diagnostic criteria: serological detection of hepatitis C antibodies and positive serum HCV-RNA by PCR for more than 6 months. Exclusion criteria were chronic hepatitis B virus infection and all other causes of chronic liver disease. Patients with HIV infection were included.
Liver Fibrosis
Not Provided
Chronic liver disease
All patients with chronic liver disease followed using FibroScan and non-invasive markers

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1830
February 2009
Not Provided

Inclusion Criteria:

  • chronic hepatitis C
  • chronic hepatitis B
  • alcoholic liver disease
  • non alcoholic steatohepatitis

Exclusion Criteria:

  • ascitis
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01241227
HLV-0403
Yes
Not Provided
Not Provided
Dr Julien Vergniol, CHU de Bordeaux
Association HGE CHU Bordeaux Sud
Not Provided
Principal Investigator: Julien Vergniol, MD Association HGE CHU Bordeaux Sud
Study Chair: Juliette Foucher, MD Association HGE CHU Bordeaux Sud
Study Chair: Eric Terrebonne, MD Association HGE CHU Bordeaux Sud
Study Chair: Wassil Merrouche Association HGE CHU Bordeaux Sud
Study Director: Victor De Ledinghen, MD, PhD Association HGE CHU Bordeaux Sud
Study Chair: Pierre-Henri Bernard, MD Association HGE CHU Bordeaux Sud
Study Chair: Couzigou Patrice, MD, PhD Association HGE CHU Bordeaux Sud
Association HGE CHU Bordeaux Sud
November 2010