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

NCT01241227 | Completed DMC

• 1 other identifier: HLV-0403
• Study Type: observational
• Target: 1,830
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Fibrosis

Keywords

liver fibrosis; survival; transient elastography

Outcome Measures

Primary Outcomes (1)

• Overall survival

  3 months

Secondary Outcomes (2)

• Survival without liver complications

  3 months

• Survival without liver transplantation

  3 months

Study Arms (1)

Chronic liver disease

All patients with chronic liver disease followed using FibroScan and non-invasive markers

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• ascitis

Sponsors & Collaborators

• Association HGE CHU Bordeaux Sud: lead

Study Sites (1)

Centre d'Investigation de la Fibrose hépatique Service Hepato-Gastroentérologie Hopital Haut-Leveque

Pessac, 33200, France

Location

Related Publications (2)

• Vergniol J, Boursier J, Coutzac C, Bertrais S, Foucher J, Angel C, Chermak F, Hubert IF, Merrouche W, Oberti F, de Ledinghen V, Cales P. Evolution of noninvasive tests of liver fibrosis is associated with prognosis in patients with chronic hepatitis C. Hepatology. 2014 Jul;60(1):65-76. doi: 10.1002/hep.27069.

  PMID: 24519328 DERIVED

• Vergniol J, Foucher J, Terrebonne E, Bernard PH, le Bail B, Merrouche W, Couzigou P, de Ledinghen V. Noninvasive tests for fibrosis and liver stiffness predict 5-year outcomes of patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1970-9, 1979.e1-3. doi: 10.1053/j.gastro.2011.02.058. Epub 2011 Mar 2.

  PMID: 21376047 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julien Vergniol, MD

  Association HGE CHU Bordeaux Sud

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Victor De Ledinghen, MD, PhD

  Association HGE CHU Bordeaux Sud

  STUDY DIRECTOR

• Pierre-Henri Bernard, MD

  Association HGE CHU Bordeaux Sud

  STUDY CHAIR

• Couzigou Patrice, MD, PhD

  Association HGE CHU Bordeaux Sud

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: November 16, 2010
• Study Start: April 1, 2003
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

FR (1)