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

France, 2010 - 2013
Reference ID
FRESH-PEF74113-en
Metadata
DDI/XML JSON
Study website Interactive tools
Created on
Feb 18, 2026
Last modified
Feb 18, 2026
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36
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Quality standards
  • Data Access
  • Contacts

    • Identification

    Survey ID number

    FRESH-PEF74113-en
    Title

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

    ORPHEE
    Country
    Name Country code
    France fr
    Kind of Data

    ['Clinical data']
    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary
    Infectious disease medicine health theme
    Viral hepatitis cim-11
    Healthcare system determinants: Use of care health determinant
    Healthcare system determinants health determinant
    Keywords
    Copegus® treatment

    Coverage

    Universe

    {"level_sex_clusion_I":[{"value":"Male","concept":{"vocab":"MeSH","vocabURI":"D008297"}},{"value":"Female","concept":{"vocab":"MeSH","vocabURI":"D005260"}}],"level_age_clusion_I":[{"value":"Young Adult (19 to 24 years)","concept":{"vocab":"MeSH","vocabURI":"D055815"}},{"value":"Adult (25 to 44 years)","concept":{"vocab":"MeSH","vocabURI":"D000328"}},{"value":"Middle Aged (45 to 64 years)","concept":{"vocab":"MeSH","vocabURI":"D008875"}},{"value":"Aged (65 to 79 years)","concept":{"vocab":"MeSH","vocabURI":"D000368"}},{"value":"Aged, 80 and over (80 years and more)","concept":{"vocab":"MeSH","vocabURI":"D000369"}}],"level_type_clusion_I":"Patients population","level_type_clusion_other":"","clusion_I":"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.","clusion_E":""}

    Producers and sponsors

    Producers
    Name Role
    F. HOFFMANN-LA ROCHE AG sponsor

    Study authorization

    Agency
    Agency name
    Other

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.)']
    Sampling Procedure

    ['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']

    Survey instrument

    Questionnaires

    Access on specific project only
    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2010-01-01 2013-01-01
    Mode of data collection
    • {"concept":{"vocabURI":"Transcription","vocab":"CESSDA"},"value":"Converting or copying information into a structured record"}
    • {"concept":{"vocabURI":"Interview","vocab":"CESSDA"},"value":"Interview with the participant (including clinical)"}

    Quality standards

    Other quality statement

    ['GCP/GVP']

    Data Access

    Availability Status

    {"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}

    Contacts

    Contacts
    Name Email
    ;Medical data center data_sharing.france@roche.com
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