Therapeutic Option for Hepatitis B and C: a French Cohort — HEPATHER  

Viral Hepatitis C Clinical Trial

Official title: Therapeutic Option for Hepatitis B and C: a French Cohort

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• Viral Hepatitis B
• Viral Hepatitis C

• NCT number: NCT01953458
• Study type: Observational
• Source: ANRS, Emerging Infectious Diseases
• Status: Active, not recruiting
• Start date: August 6, 2012
• Completion date: December 31, 2024