HEPATYS - Cohort study on management and outcome of patients with chronic Hepatitis C treated with PEG-IFN-alpha2a in combinaison with ribavirin in hospital-based or private office-based ARCHIVE

Head :
Pinta Alexandrina, ROCHE

Last update : 09/05/2017 | Version : 2 | ID : 177

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Cohort study on management and outcome of patients with chronic Hepatitis C treated with PEG-IFN-alpha2a in combinaison with ribavirin in hospital-based or private office-based
Sign or acronym HEPATYS
General Aspects
Medical area Gastroenterology et hepatology
Keywords chronic hepatitis C, Pegasys
Scientific investigator(s) (Contact)
Name of the director Pinta
Surname Alexandrina
Phone +33 (0)1 46 40 43 76
Email alexandrina.pinta@roche.com
Unit ROCHE
Collaborations
Funding
Funding status Private
Details Roche
Governance of the database
Sponsor(s) or organisation(s) responsible ROCHE
Organisation status Private
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Longitudinal study (except cohorts)
Database recruitment is carried out by an intermediary A selection of health care professionals
A selection of health institutions and services
Database recruitment is is made on the basis of: Medication(s) taken
Database recruitment is carried out as part of an interventional study No
Database objective
Main objective Describe the management and outcome of patients with chronic Hepatitis C treated with PEG-IFN-alpha2a in combinaison with ribavirin in hospital-based or private office-based
Inclusion criteria Patients suffering from chronic hepatitis C for whom a treatment via Pagasys was decided and then initiated, followed in a hospital and general environment
Patients who have been informed of the study orally and in writing
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2003
Date of last collection (YYYY or MM/YYYY) 2006
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 2155
Data
Database activity Data collection completed
Type of data collected Clinical data
Biological data
Clinical data (detail) Direct physical measures
Biological data (detail) HCV viral load, Hb, Platelets, Leukocytes, creatinine
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Health care consumption and services
Quality of life/health perception
Care consumption (detail) Hospitalization
Medical/paramedical consultation
Medicines consumption
Procedures
Participant monitoring Yes
Links to administrative sources No
Promotion and access
Promotion
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/?term=Pinta+A[author]+AND+hepatys
Description List of publications in Pubmed
Access
Terms of data access (charter for data provision, format of data, availability delay) Oral and posted communication at the hepatology congress (AFEF (French Association for the study of the liver), AASLD (American Association for the Study of Liver Diseases), JFHOD (French-Speaking Days on Hepato-Gastroenterology and Digestive Oncology)), infectiology (RICAI (Interdisciplinary Meeting on Anti-Infective Chemotherapy)), pharmaco-economics, pharmaco-epidemiology
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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