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NCT00843076 Clinical Trial

Impact of Hepatitis C Virus Variability on Steatosis

Chronic Hepatitis C Clinical Trial

— Viro-steatosis  

Official title:
Impact of the Hepatitis C Virus Variability on Liver Steatosis

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00843076
Other study ID # AORT08-PR/VIRO-Stéatose
Secondary ID
Status Terminated
Phase N/A
First received February 12, 2009
Last updated November 8, 2013
Start date January 2009
Est. completion date April 2011

Study information
Verified date November 2013
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

Chronic infection by the hepatitis C virus (HCV) is a common cause of liver disease, which may progress to cirrhosis and eventually liver cancer. The therapeutic indication will depend mainly on the importance of liver damage (fibrosis), which can be assessed by physical techniques, blood tests and a liver biopsy. The overall objectives of the project are to understand how HCV variability may influence the severity of steatosis (accumulation of fat in the liver), studying 30 patients chronically infected with HCV (half of these patients infected by HCV genotype 3, versus the other half infected by HCV of another genotype). A small portion of the biopsy performed for the routine pathology examination will be placed in special fixation buffer for electron microscopy (EM). Counting and measuring the size of lipid droplets present in the liver by EM will be used to precisely quantify and characterize the liver steatosis. A blood sample of patients will also be collected to sequence the viral genome present in the patient and identify the amino acids involved in an increase in intracellular accumulation of lipid droplets. This work should clarify the impact of the viral variability in the severity of steatosis. Ultimately, the identification of viral sequences responsible for an increase of this phenomenon could be crucial for understanding the mechanisms involved in the steatosis.

Recruitment information / eligibility
Status Terminated
Enrollment 27
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients with chronic hepatitis C, naive of an antiviral treatment or after relapse or non-response for an antiviral treatment stopped for more than 1 year

- Liver biopsy necessary for the care of the patient

- Signature of informed consent

Exclusion Criteria:

- Patients for which the liver biopsy is estimated = 18 mm, so a portion of 3 mm could not be devoted for the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France CH de Blois Blois
France CH de Bourges Bourges
France CH de Châteauroux Chateauroux
France CH de Dreux Dreux
France CHR Orléans Orleans
France CHRU de Tours Tours

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

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