Therapeutic Option for Hepatitis B and C: a French Cohort
Information source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Viral Hepatitis B; Viral Hepatitis C
Phase: N/A
Status: Recruiting
Sponsored by: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) Official(s) and/or principal investigator(s): Stanislas POL, MD, PhD, Principal Investigator, Affiliation: Hôpital Cochin, PARIS
Overall contact: Fabrice CARRAT, MD, PhD, Phone: +33144738458, Email: fabrice.carrat@upmc.fr
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.
Clinical Details
Official title: Therapeutic Option for Hepatitis B and C: a French Cohort
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: There is no specific primary outcome measure but we indicated below (see Description) a list of potential outcome measures according to the objectives.
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Fabrice CARRAT, MD, PhD, Phone: +33144738458, Email: fabrice.carrat@upmc.fr
All the Regions of the Country (36 Centers), France; Recruiting Stanislas POL, MD, PhD, Email: stanislas.pol@cch.aphp.fr Hélène FONTAINE, MD, Email: helene.fontaine@cch.aphp.fr
Additional Information
Related Info
Starting date: August 2012
Last updated: September 5, 2014
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