Therapeutic Option for Hepatitis B and C: a French Cohort

Viral Hepatitis C Clinical Trial

— HEPATHER  

Official title:

Therapeutic Option for Hepatitis B and C: a French Cohort

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01953458
• Other study ID #: ANRS CO22 HEPATHER
• Secondary ID: 2011-A01438-33
• Status: Active, not recruiting
• Start date: August 6, 2012
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20902
• Est. completion date: December 31, 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• Viral Hepatitis B
• Viral Hepatitis C

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag Ltd., Merck Sharp & Dohme LLC, Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	There is no specific primary outcome measure but we indicated below (see Description) a list of potential outcome measures according to the objectives.	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)

External Links

•   Related Info