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

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ClinicalTrials.gov Identifier: NCT01953458
Recruitment Status : Unknown
Verified October 2017 by ANRS, Emerging Infectious Diseases.
Recruitment status was:  Recruiting
First Posted : October 1, 2013
Last Update Posted : October 5, 2017
Bristol-Myers Squibb
Gilead Sciences
Janssen-Cilag Ltd.
Merck Sharp & Dohme LLC
Roche Pharma AG
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

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.

Condition or disease
Viral Hepatitis B Viral Hepatitis C

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

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Study Type : Observational
Estimated Enrollment : 25000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

hepatitis C and/or B

Primary Outcome Measures :
  1. 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
whole blood, serum, plasma and urine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HBV-positive patients and/or HCV-positive patients

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
    • Acute hepatitis B defined as a recent appearance (<6 months) of detectable HBs Ag,
    • Chronic hepatitis B with serological remission HbsAg-negative , HB DNA-negative,
    • 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
    • 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 spontaneous, a positive anti-HCV antibodies associated to a negative RNA at two collection - 6 months interval time; either treatment defined by negative viremia 3 month after end of treatment.

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
  • Patients end of life
  • Woman whose pregnancy is known

Information from the National Library of Medicine

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

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Contact: Fabrice CARRAT, MD, PhD +33144738458 fabrice.carrat@upmc.fr
Contact: Céline DORIVAL, PhD +33144738668 celine.dorival@upmc.fr

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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
ANRS, Emerging Infectious Diseases
Bristol-Myers Squibb
Gilead Sciences
Janssen-Cilag Ltd.
Merck Sharp & Dohme LLC
Roche Pharma AG
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Principal Investigator: Stanislas POL, MD, PhD Hôpital Cochin, PARIS
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT01953458    
Other Study ID Numbers: ANRS CO22 HEPATHER
2011-A01438-33 ( Other Identifier: ID RCB )
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Keywords provided by ANRS, Emerging Infectious Diseases:
Hepatitis B and C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections