Therapeutic Option for Hepatitis B and C: a French Cohort (HEPATHER)
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|ClinicalTrials.gov Identifier: NCT01953458|
Recruitment Status : Recruiting
First Posted : October 1, 2013
Last Update Posted : October 5, 2017
- 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.
|Condition or disease|
|Viral Hepatitis B Viral Hepatitis C|
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
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%).
- 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 :
- 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
- 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
- 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 Type :||Observational|
|Estimated Enrollment :||25000 participants|
|Official Title:||Therapeutic Option for Hepatitis B and C: a French Cohort|
|Actual Study Start Date :||August 6, 2012|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
|hepatitis C and/or B|
- There is no specific primary outcome measure but we indicated below (see Description) a list of potential outcome measures according to the objectives. [ Time Frame: From recruitment to the end of the cohort, with a minimum of one medical visit per year (the duration of follow-up is 7-8 years) ]
- Effectiveness of HCV or HBV treatments: Virological response, seroconversion, loss of agHbS, liver fibrosis or clinical response (including quality of life), safety.
- Prognostic factors of HCV or HBV infection: liver fibrosis, cirrhosis, clinical or biological event.
- Biomarker studies: Virological response, seroconversion, loss of agHbS, liver fibrosis, clinical or biological event, safety
- Cost-effectiveness studies: cost perYLS, cost per QALY
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953458
|Contact: Fabrice CARRAT, MD, PhDfirstname.lastname@example.org|
|Contact: Céline DORIVAL, PhDemail@example.com|
|All the Regions of the Country (36 Centers), France|
|Contact: Stanislas POL, MD, PhD firstname.lastname@example.org|
|Contact: Hélène FONTAINE, MD email@example.com|
|Principal Investigator:||Stanislas POL, MD, PhD||Hôpital Cochin, PARIS|