Impact of Hepatitis C Virus Variability on Steatosis
Viro-steatosis
Impact of the Hepatitis C Virus Variability on Liver Steatosis
1 other identifier
observational
27
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2009
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 12, 2009
CompletedFirst Posted
Study publicly available on registry
February 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedNovember 11, 2013
November 1, 2013
2.2 years
February 12, 2009
November 8, 2013
Conditions
Eligibility Criteria
Patients with chronic hepatitis C
You may qualify if:
- 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
You may not qualify if:
- Patients for which the liver biopsy is estimated ≤ 18 mm, so a portion of 3 mm could not be devoted for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
CH de Blois
Blois, France
CH de Bourges
Bourges, France
CH de Châteauroux
Châteauroux, France
CH de Dreux
Dreux, France
CHR Orléans
Orléans, France
CHRU de Tours
Tours, France
Biospecimen
Liver biopsy Blood sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Philippe ROINGEARD
INSERM ERI 19
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 12, 2009
First Posted
February 13, 2009
Study Start
January 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
November 11, 2013
Record last verified: 2013-11