COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Impact of Hepatitis C Virus Variability on Steatosis (Viro-steatosis)

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. Identifier: NCT00843076
Recruitment Status : Terminated
First Posted : February 13, 2009
Last Update Posted : November 11, 2013
Information provided by:
University Hospital, Tours

Brief 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.

Condition or disease
Chronic Hepatitis C

Layout table for study information
Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of the Hepatitis C Virus Variability on Liver Steatosis
Study Start Date : January 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples With DNA

Liver biopsy

Blood sample

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic hepatitis C

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00843076

Layout table for location information
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, France
Sponsors and Collaborators
University Hospital, Tours
Layout table for investigator information
Study Director: Philippe ROINGEARD INSERM ERI 19
Layout table for additonal information
Responsible Party: University Hospital, Tours Identifier: NCT00843076    
Other Study ID Numbers: AORT08-PR/VIRO-Stéatose
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic