ORPHEE - Prospective cohort study on the impact of insulin resistance on sustained virological response to Pegasys® and Copegus® treatment in patients with Chronic Hepatitis-C

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Medical data center

Last update : 01/18/2022 | Version : 1 | ID : 74113


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General Aspects
Scientific investigator(s) (Contact)
Governance of the database
Additional contact
Type of database
Database objective
Population type
Size of the database
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French version
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
Email data_sharing_france@roche.com
Organization Roche SAS
Participation in projects, networks and consortia No
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
Geography area National
Data collection
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
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
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
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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