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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


- 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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Page last updated: August 20, 2015

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