Viral Hepatitis C Clinical Trial
Official title:
Therapeutic Option for Hepatitis B and C: a French Cohort
- The cohort will integrate clinical, genetic, pharmacogenomics, environmental, biomarkers and behavioral data in a large number of patients and will be a leading equipment for crossdisciplinary and translational research on hepatitis. - The cohort will be the main support for estimating the relative effects of treatments and for further cost-effectiveness studies on the management and treatment options in chronic HCV (Hepatitis C Virus)and HBV (Hepatitis B virus)infections.
General schedule of the study : - Prospective multicenter national study - Duration of inclusions:3 years - Effective : 25000 patients - Duration of the follow-up: 7-8 years - Duration of the cohort: 10 years Population : Twenty-five thousands of people will be included and followed in investigator sites, 15000 with an hepatitis C and 10000 with an hepatitis B, according their usual follow-up of their liver disease. We aim to include up to 50% patients naive of any HCV treatment at inclusion. Also HBV "cured" patients could be included (less than 10%). Design study: - During the recruitment visit, demographics, clinical, biological and virological data will be collected. The patient will move through several assessments involving questionnaires, measurements and blood sampling. - Then the minimum follow-up is one medical visit per year. The follow-up (clinical data and biological collections) will be driven by events or based on protocols that will be developed on the cohort. - There is no specific treatment in this cohort. The scientific project is structured into 4 scientific thematic axes : - Therapeutics: - To analyze the long term effects of therapy - To study predictors of virological response or fibrosis progression (or regression)and pharmacokinetic/pharmacodynamics either in HCV or HBV treatments - Virology: - To understand the molecular mechanisms of antiviral treatment success and failure - To provide treatment recommendation to prevent resistance and achieve sustained or definitive control of infection - Pathology and physiopathology : - To identify new pathophysiological targets responsible for chronic hepatitis severity,prognosis, and evolution. - To validate new therapeutic combinations based on pathophysiological researches - Public Health: - To identify psychosocial and behavioral correlates of access to care, progression of liver disease and of the burden of chronic viral hepatitis B and C. - To evaluate the cost-effectiveness of HBV and HCV treatments and quality of life ;
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