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

January 30, 2023 updated by: ANRS, Emerging Infectious Diseases
  • 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.

Study Overview

Status

Active, not recruiting

Conditions

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

Study Type

Observational

Enrollment (Actual)

20902

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Multiple Locations, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HBV-positive patients and/or HCV-positive patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
hepatitis C and/or B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Bristol-Myers Squibb
Merck Sharp & Dohme LLC
Gilead Sciences
Roche Pharma AG
Janssen-Cilag Ltd.

Investigators

  • Principal Investigator: Stanislas POL, MD, PhD, Hôpital Cochin, PARIS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2012

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 26, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Actual)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS CO22 HEPATHER
  • 2011-A01438-33 (Other Identifier: ID RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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