Therapeutic Option for Hepatitis B and C: a French Cohort (HEPATHER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
|Principal Investigator:||Stanislas POL, MD, PhD||Hôpital Cochin, PARIS|