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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 : Recruiting
First Posted : October 1, 2013
Last Update Posted : October 5, 2017
Sponsor:
Collaborators:
Bristol-Myers Squibb
Gilead Sciences
Janssen-Cilag Ltd.
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)

Tracking Information
First Submitted Date September 19, 2013
First Posted Date October 1, 2013
Last Update Posted Date October 5, 2017
Actual Study Start Date August 6, 2012
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 5, 2014)
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
Original Primary Outcome Measures
 (submitted: September 26, 2013)
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) ]
By integrating genetic, pharmacogenomics, clinical, environmental and behavioral data from a large number of patients
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: September 26, 2013)
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Therapeutic Option for Hepatitis B and C: a French Cohort
Official Title Therapeutic Option for Hepatitis B and C: a French Cohort
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood, serum, plasma and urine
Sampling Method Non-Probability Sample
Study Population HBV-positive patients and/or HCV-positive patients
Condition
  • Viral Hepatitis B
  • Viral Hepatitis C
Intervention Not Provided
Study Groups/Cohorts hepatitis C and/or B
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 26, 2013)
25000
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility 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
    • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Fabrice CARRAT, MD, PhD +33144738458 fabrice.carrat@upmc.fr
Contact: Céline DORIVAL, PhD +33144738668 celine.dorival@upmc.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01953458
Other Study ID Numbers ANRS CO22 HEPATHER
2011-A01438-33 ( Other Identifier: ID RCB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Study Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators
  • Bristol-Myers Squibb
  • Gilead Sciences
  • Janssen-Cilag Ltd.
  • Merck Sharp & Dohme Corp.
  • Roche Pharma AG
Investigators
Principal Investigator: Stanislas POL, MD, PhD Hôpital Cochin, PARIS
PRS Account French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date October 2017