Last update : 09/05/2017 | Version : 2 | ID : 124
General | |
Identification | |
Detailed name | A cross-sectional, multicentre, epidemiological study of the drug management in hepatitis B |
Sign or acronym | Episurvey Hepatite B |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL 833542 version 9 |
General Aspects | |
Medical area |
Infectious diseases |
Others (details) | hepatitis B |
Keywords | Chronic hepatitis B, epidemiology, treatment |
Scientific investigator(s) (Contact) | |
Name of the director | Bregman |
Surname | Bruno |
Address | 3, rue J. Monnier - 92500 Rueil Malmaison |
Phone | +33 (0)1 58 83 60 00 |
bruno.bregman@bms.com | |
Unit | Bristol-Myers Squibb |
Name of the director | Schmidely |
Surname | Nathalie |
Address | 3, rue J. Monnier - 92500 Rueil Malmaison |
Phone | +33 (0)1 58 83 60 00 |
nathalie.schmidely@bms.com | |
Unit | Bristol-Myers Squibb |
Collaborations | |
Funding | |
Funding status |
Private |
Details | Bristol-Myers Squibb |
Governance of the database | |
Sponsor(s) or organisation(s) responsible | Bristol-Myers Squibb France (BMS) |
Organisation status |
Private |
Additional contact | |
Main features | |
Type of database | |
Type of database |
Study databases |
Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
Database recruitment is carried out as part of an interventional study |
No |
Additional information regarding sample selection. | Random sampling in clusters |
Database objective | |
Main objective | Describe the drug management of patients having chronic hepatitis B, in France, in 2006. |
Inclusion criteria | M/F >=18 years, infected by the hepatitis B virus for at least 6 months, seen in outpatient clinic visit at expert centers for caring of hepatitis (Hepatitis Referenced University Hospitals, General Hospital Centres, community-based hepato-gastroenterologists) between 1 Jan. and 31 March 2006. |
Population type | |
Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
Population covered |
General population |
Gender |
Male Woman |
Geography area |
National |
Detail of the geography area | Metropolitan France |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 2006 |
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 | 1800 |
Data | |
Database activity |
Data collection completed |
Type of data collected |
Clinical data Biological data |
Clinical data (detail) |
Direct physical measures |
Biological data (detail) | ALT, HBe status, viral load |
Presence of a biobank |
No |
Health parameters studied |
Health event/morbidity |
Procedures | |
Data collection method | Case report form |
Participant monitoring |
No |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
Access | |
Terms of data access (charter for data provision, format of data, availability delay) | Publications |
Access to aggregated data |
Access on specific project only |
Access to individual data |
Access on specific project only |
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