Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01953458
Brief 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
Study:
NCT01953458
Study Brief:
Protocol Section:
NCT01953458