ITMO public health
Last update : 01/18/2022 | Version : 1 | ID : 74113
| General | |
| Identification | |
| Detailed name | Prospective cohort study on the impact of insulin resistance on sustained virological response to Pegasys® and Copegus® treatment in patients with Chronic Hepatitis-C |
| Sign or acronym | ORPHEE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | ML22790 |
| General Aspects | |
| Medical area |
Infectious diseases |
| Study in connection with Covid-19 |
No |
| Pathology (details) | Chronic hepatitis-C |
| Health determinants |
Medicine |
| Keywords | Copegus® treatment |
| Scientific investigator(s) (Contact) | |
| Name of the director | Medical data center |
| data_sharing_france@roche.com | |
| Organization | Roche SAS |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Funding status |
Private |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Roche SAS |
| Organisation status |
Private |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
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 |
Primary objective : To describe in real-life conditions the insulin resistance and its impact on SVR in patients presenting with chronic hepatitis C and treated with Pegasys® and Copegus®.
Secondary objectives : - To describe patients’ characteristics at inclusion - To describe the predictive factors influencing virological response under treatment at W4 (rapid virological response, RVR), at W12 (early virological response, EVR), and 24 weeks after the end of treatment with Pegasys® (sustained virological response, SVR) - To describe the constitutive parameters of metabolic syndrome during the study period - To describe the management of chronic hepatitis C and insulin resistance - To describe the changes in patients’ quality of life during the study period - To describe the serious and non-serious adverse events occurring during the study period. |
| Inclusion criteria |
Inclusion criteria :
- Adult patient (age >=18 years) - Suffering from chronic hepatitis C (detectable blood HCV RNA) - For whom the specialist had decided to initiate dual therapy with Pegasys® and Copegus® - Who received both oral and written information about the study, without any objections for the use of his/her personal data. |
| 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 |
Sick population |
| Pathology | B15-B19 - Viral hepatitis |
| Gender |
Male Woman |
| Geography area |
National |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2010 |
| Date of last collection (YYYY or MM/YYYY) | 2013 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1150 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Validation of selection criteria ; Patients’ demographics (age and sex) ; Pregnancy test for women of childbearing age ; Clinical data ; Co-morbidities and associated factors ; History of chronic C hepatitis ; Most recent biological data ; Most recent histological data ; Treatment with Pegasys® and Copegus® ; Date of permanent discontinuation of Pegasys® treatment and reason(s) ; Lifestyle and therapeutic recommendations, concomitant treatments ; Adverse events ; Date and reason of early study withdrawal ; Quality of life questionnaire (HQLQ). |
| Presence of a biobank |
No |
| Procedures | |
| Quality procedure(s) used | GCP/GVP |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the referring doctor |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Dedicated website | https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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