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NCT01241227 Clinical Trial

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

Liver Fibrosis Clinical Trial

— PVTE  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01241227
Other study ID # HLV-0403
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2003
Est. completion date February 2009

Study information
Verified date July 2023
Source Association HGE CHU Bordeaux Sud
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 1830
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - chronic hepatitis C - chronic hepatitis B - alcoholic liver disease - non alcoholic steatohepatitis Exclusion Criteria: - ascitis

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre d'Investigation de la Fibrose hépatique Service Hepato-Gastroentérologie Hopital Haut-Leveque Pessac

Sponsors (1)
Lead Sponsor Collaborator
Association HGE CHU Bordeaux Sud

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival 3 months
Secondary Survival without liver complications 3 months
Secondary Survival without liver transplantation 3 months
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