NCT01953458

Therapeutic Option for Hepatitis B and C: a French Cohort

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20,902 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* 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.

Detailed description

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

Conditions

• Viral Hepatitis B
• Viral Hepatitis C

Timeline

• Start date: 2012-08-06
• Primary completion: 2024-12-01
• Completion: 2024-12-31
• First posted: 2013-10-01
• Last updated: 2023-01-31

Locations

1 site across 1 country: France