Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT01953458
Status:
UNKNOWN
Last Update Posted:
2023-01-31
First Post:
2013-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Option for Hepatitis B and C: a French Cohort
Sponsor:
ANRS, Emerging Infectious Diseases
Organization:
Study Overview
Official Title:
Therapeutic Option for Hepatitis B and C: a French Cohort
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEPATHER
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.
* 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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-A01438-33 | OTHER | ID RCB | View |