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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Collaborators:
Bristol-Myers Squibb
Gilead Sciences
Janssen-Cilag Ltd.
Janssen Pharmaceuticals
Merck Sharp & Dohme Corp.
Roche Pharma AG
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01953458
First received: September 19, 2013
Last updated: September 26, 2013
Last verified: September 2013
  Purpose
  • 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
Viral Hepatitis B
Viral Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Therapeutic Option for Hepatitis B and C: a French Cohort

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • To improve quality and effectiveness of medical care in Hepatitis B or C taking into account new treatment options and host characteristics [ 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 8 years) ] [ Designated as safety issue: Yes ]
    By integrating genetic, pharmacogenomics, clinical, environmental and behavioral data from a large number of patients


Secondary Outcome Measures:
  • To describe the epidemiology of HBV and HCV chronic infections in a context where the screening and early diagnosis of viral infection and genetic biomarkers research are increasing and evolving [ 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 8 years) ] [ Designated as safety issue: No ]
  • To obtain original data on efficacy and safety of new hepatitis treatments in real‐life with long term follow‐up, allowing the estimation of the public‐health impact of these treatments in terms of reduction of morbidity or mortality. [ 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 8 years) ] [ Designated as safety issue: Yes ]
  • Cross‐disciplinary and translational research on hepatitis based on a scientific/clinical expert network and a biobank creation [ 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 8 years) ] [ Designated as safety issue: No ]
  • To offer outstanding competency and resources for the design of clinical trials on specific sub‐populations and postmarketing (phase IV) studies [ 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 8 years) ] [ Designated as safety issue: Yes ]
  • To elaborate and compare cost‐effectiveness strategies for the management and treatment per patient class [ 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 8 years) ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

whole blood, serum, plasma and urine


Estimated Enrollment: 25000
Study Start Date: August 2012
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
hepatitis C and/or B

Detailed Description:

General schedule of the study :

  • Prospective multicenter national study
  • Duration of inclusions: 2 years
  • Effective : 25000 patients
  • Duration of the follow-up: 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.

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HBV-positive patients and/or HCV-positive patients

Criteria

Inclusion Criteria:

  • HBV-positive patients

    • Chronic hepatitis B defined by a positive HBsAg ( surface antigen of the hepatitis B virus) for at least 6 months, with less than 30% of inactive carriers,
    • Acute hepatitis B defined as a recent appearance (<6 months) of detectable HBs Ag,
    • Patients with "cured" chronic hepatitis B, spontaneously or under treatment - less than 10%
    • With or without association with acute or chronic hepatitis D.
  • HCV-positive patients

    • Chronic hepatitis C defined by the positivity for anti-HCV antibodies for at least 6 months and positive HCV-RNA. At least 50% patients naive of any HCV treatment,
    • Acute hepatitis C defined by the recent appearance of HCV RNA (less than 6 months) in patients with risk factors (with or without positive antibodies)
    • Patients with cured hepatitis C defined by long-term eradication, either treatment, either spontaneous, a positive anti-HCV antibodies associated to a negative RNA at two collections with 6 months interval (these patients should represent less than 10% of patients).

Exclusion Criteria:

  • HIV co-infected patients are not eligible to the cohort.
  • So-called vulnerable populations (minors, people under guardianship or protection, or a private individual under protection from making legal or administrative decisions)
  • Treatment ongoing hepatitis C during or stopped since less than 3 months
  • Life expectancy of less than 1 year
  • Woman whose pregnancy is known
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953458

Contacts
Contact: Fabrice CARRAT, MD, PhD +33144738458 carrat@U707.jussieu.fr
Contact: Céline DORIVAL, PhD +33144738668 dorival@U707.jussieu.fr

Locations
France
Recruiting
All the Regions of the Country (36 Centers), France
Contact: Stanislas POL, MD, PhD       stanislas.pol@cch.aphp.fr   
Contact: Hélène FONTAINE, MD       helene.fontaine@cch.aphp.fr   
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Bristol-Myers Squibb
Gilead Sciences
Janssen-Cilag Ltd.
Janssen Pharmaceuticals
Merck Sharp & Dohme Corp.
Roche Pharma AG
Investigators
Principal Investigator: Stanislas POL, MD, PhD Hôpital Cochin, PARIS
  More Information

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT01953458     History of Changes
Other Study ID Numbers: ANRS CO22 HEPATHER, 2011-A01438-33
Study First Received: September 19, 2013
Last Updated: September 26, 2013
Health Authority: France : ANSM - Agence Nationale de Sécurité du Médicament et des produits de santé (French national competent authority)

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Hepatitis B and C
ANRS HEPATHER French Cohort

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on August 26, 2014