Episurvey Hepatite B - A cross-sectional, multicentre, epidemiological study of the drug management in hepatitis B 
Head :
Bregman Bruno, Bristol-Myers Squibb
Schmidely Nathalie, Bristol-Myers Squibb
Schmidely Nathalie, Bristol-Myers Squibb
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 |
