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        <titl xml:lang="FR">Etude longitudinale sur des patients atteints d'hépatite chronique C : étude de l'utilisation de Pegasys® en milieu hospitalier et libéra</titl>
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        <altTitl xml:lang="FR">HEPATYS</altTitl>
        <altTitl xml:lang="EN">HEPATYS</altTitl>
        <parTitl xml:lang="EN">Cohort study on management and outcome of patients with chronic Hepatitis C treated with PEG-IFN-alpha2a in combinaison with ribavirin in hospital-based or private office-based</parTitl>
        <IDNo>PEF177</IDNo>
      </titlStmt>
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        <AuthEnty affiliation="ITMO Santé Publique, Aviesan">Portail Épidémiologie-France</AuthEnty>
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        <producer abbr="PEF-HD" affiliation="ITMO Santé Publique, Aviesan">Portail Épidémiologie-France | Health Databases</producer>
        <copyright>Portail Épidémiologie-France 2026</copyright>
        <prodDate date="2026-04-08">08/04/2026</prodDate>
        <prodPlac>https://epidemiologie-france.aviesan.fr/</prodPlac>
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        <distrbtr>Portail Épidémiologie-France</distrbtr>
        <contact email="portail-epidemiologie@inserm.fr">Portail Epidemiologie-France</contact>
        <depositr>Alexandrina Pinta</depositr>
        <depDate xml:lang="FR">16/12/2010</depDate>
        <depDate xml:lang="EN">03/02/2012</depDate>
        <distDate>05/09/2017</distDate>
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        <version xml:lang="FR" date="05/09/2017">2</version>
        <version xml:lang="EN" date="05/09/2017">2</version>
        <verResp>Alexandrina Pinta</verResp>
        <notes/>
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      <holdings xml:lang="FR" location="Portail Epidemiologie-France" URI="http://epidemiologie-france.aviesan.fr/en/content/view/full/84263">HEPATYS - Etude longitudinale sur des patients atteints d'hépatite chronique C : étude de l'utilisation de Pegasys® en milieu hospitalier et libéra</holdings>
      <holdings xml:lang="EN" location="Portail Epidemiologie-France" URI="http://epidemiologie-france.aviesan.fr/en/content/view/full/84264">HEPATYS - Cohort study on management and outcome of patients with chronic Hepatitis C treated with PEG-IFN-alpha2a in combinaison with ribavirin in hospital-based or private office-based</holdings>
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        <titl xml:lang="FR">Etude longitudinale sur des patients atteints d'hépatite chronique C : étude de l'utilisation de Pegasys® en milieu hospitalier et libéra</titl>
        <subTitl/>
        <altTitl xml:lang="FR">HEPATYS</altTitl>
        <altTitl xml:lang="EN">HEPATYS</altTitl>
        <parTitl xml:lang="EN">Cohort study on management and outcome of patients with chronic Hepatitis C treated with PEG-IFN-alpha2a in combinaison with ribavirin in hospital-based or private office-based</parTitl>
        <IDNo/>
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        <AuthEnty affiliation="">Alexandrina Pinta</AuthEnty>
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        <producer role="Private">ROCHE</producer>
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        <prodPlac>ROCHE -  - </prodPlac>
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        <fundAg xml:lang="FR" role="Privé">Roche</fundAg>
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        <contact affiliation="" email="alexandrina.pinta@roche.com">Alexandrina Pinta</contact>
        <depositr>Alexandrina Pinta</depositr>
        <depDate xml:lang="FR">16/12/2010</depDate>
        <depDate xml:lang="EN">03/02/2012</depDate>
        <distDate xml:lang="FR">05/09/2017</distDate>
        <distDate xml:lang="EN">05/09/2017</distDate>
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        <version xml:lang="FR" date="05/09/2017">2</version>
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        <verResp>Alexandrina Pinta</verResp>
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    <studyAuthorization>
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        <keyword xml:lang="FR">hépatite chronique C</keyword>
        <keyword xml:lang="FR">Pegasys</keyword>
        <keyword xml:lang="EN">chronic hepatitis C</keyword>
        <keyword xml:lang="EN">Pegasys</keyword>
        <topcClas xml:lang="FR">Gastro-entérologie et hépatologie</topcClas>
        <topcClas xml:lang="EN">Gastroenterology et hepatology</topcClas>
        <topcClas xml:lang="FR">Produits de santé</topcClas>
        <topcClas xml:lang="EN"/>
      </subject>
      <abstract xml:lang="FR">Objectif de la base de données : Décrire l'utilisation de Pegasys en "situation réelle", chez des patients atteint d'hépatite chronique C</abstract>
      <abstract xml:lang="EN">Database objective : Describe the management and outcome of patients with chronic Hepatitis C treated with PEG-IFN-alpha2a in combinaison with ribavirin in hospital-based or private office-based</abstract>
      <sumDscr>
        <timePrd/>
        <collDate event="start">2003</collDate>
        <collDate event="end">2006</collDate>
        <collDate xml:lang="FR">Collecte des données terminée</collDate>
        <collDate xml:lang="EN">Data collection completed</collDate>
        <nation>France</nation>
        <geogCover xml:lang="FR">France</geogCover>
        <geogCover xml:lang="EN">France</geogCover>
        <geogUnit>National</geogUnit>
        <anlyUnit xml:lang="fr">individuel
                </anlyUnit>
        <anlyUnit xml:lang="en">individuals
                </anlyUnit>
        <universe xml:lang="FR" clusion="I">Patients atteints d'hépatite chronique C pour lesquels un traitement par Pagasys a été décidé puis initié, suivis en milieu hospitalier et libéral&#13;
Patients ayant été informés de l'étude par oral et par écrit</universe>
        <universe xml:lang="EN" clusion="I">Patients suffering from chronic hepatitis C for whom a treatment via Pagasys was decided and then initiated, followed in a hospital and general environment&#13;
Patients who have been informed of the study orally and in writing</universe>
        <universe xml:lang="FR">Nombre d'individus : 2155</universe>
        <universe xml:lang="EN">Number of individuals: 2155</universe>
        <universe xml:lang="FR">Recrutement via une sélection de professionnels d'exercice libéral</universe>
        <universe xml:lang="FR">Recrutement via une sélection de services ou établissements de santé</universe>
        <universe xml:lang="EN">Recruiting through a selection of health care professionals</universe>
        <universe xml:lang="EN">Recruiting through a selection of health institutions and services</universe>
        <universe xml:lang="FR">sur la base Prise de produit(s) de santé</universe>
        <universe xml:lang="EN">based on Medication(s) taken</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Adulte (19 à 24 ans)</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Adulte (25 à 44 ans)</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Adulte (45 à 64 ans)</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Personnes âgées (65 à 79 ans)</universe>
        <universe xml:lang="EN" level="Age range">Adulthood (19 to 24 years)</universe>
        <universe xml:lang="EN" level="Age range">Adulthood (25 to 44 years)</universe>
        <universe xml:lang="EN" level="Age range">Adulthood (45 to 64 years)</universe>
        <universe xml:lang="EN" level="Age range">Elderly (65 to 79 years)</universe>
        <universe xml:lang="FR" level="Type de population">Sujets malades</universe>
        <universe xml:lang="EN" level="Population type">Sick population</universe>
        <universe xml:lang="FR" level="Sexe">Masculin</universe>
        <universe xml:lang="FR" level="Sexe">Féminin</universe>
        <universe xml:lang="EN" level="Sex">Male</universe>
        <universe xml:lang="EN" level="Sex">Female</universe>
        <dataKind xml:lang="FR">Bases de données issues d’enquêtes</dataKind>
        <dataKind xml:lang="EN">Study databases</dataKind>
        <dataKind xml:lang="FR">Etudes longitudinales (hors cohortes)</dataKind>
        <dataKind xml:lang="EN">Longitudinal study (except cohorts)</dataKind>
        <dataKind xml:lang="FR">Données cliniques : </dataKind>
        <dataKind xml:lang="FR">Données biologiques : Charge virale VHC, Hb, Plaquettes , Globules blancs, créatinine</dataKind>
        <dataKind xml:lang="EN">Clinical data: </dataKind>
        <dataKind xml:lang="EN">Biological data: HCV viral load, Hb, Platelets, Leukocytes, creatinine</dataKind>
        <dataKind xml:lang="FR">Evénements de santé/morbidité</dataKind>
        <dataKind xml:lang="FR">Evénements de santé/mortalité</dataKind>
        <dataKind xml:lang="FR">Consommation de soins/services de santé</dataKind>
        <dataKind xml:lang="FR">Qualité de vie/santé perçue</dataKind>
        <dataKind xml:lang="EN">Health event/morbidity</dataKind>
        <dataKind xml:lang="EN">Health event/mortality</dataKind>
        <dataKind xml:lang="EN">Health care consumption and services</dataKind>
        <dataKind xml:lang="EN">Quality of life/health perception</dataKind>
        <dataKind xml:lang="FR">Hospitalisation</dataKind>
        <dataKind xml:lang="FR">Consultations (médicales/paramédicales)</dataKind>
        <dataKind xml:lang="FR">Produits de santé</dataKind>
        <dataKind xml:lang="EN">Hospitalization</dataKind>
        <dataKind xml:lang="EN">Medical/paramedical consultation</dataKind>
        <dataKind xml:lang="EN">Medicines consumption</dataKind>
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        <dataCollector affiliation="">Alexandrina Pinta</dataCollector>
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        <frequenc xml:lang="FR"/>
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        <collMode xml:lang="FR">Dossier clinique : </collMode>
        <collMode xml:lang="EN">Direct physical measures: </collMode>
        <collMode xml:lang="FR">Charge virale VHC, Hb, Plaquettes , Globules blancs, créatinine</collMode>
        <collMode xml:lang="EN">HCV viral load, Hb, Platelets, Leukocytes, creatinine</collMode>
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        <avlStatus xml:lang="FR">Communications orales et affichées aux Congrès d'hépatologie (AFEF, AASLD, JFHOD), d'infectiologie (RICAI), pharamacoéconomie, pharmacoépidémiologie</avlStatus>
        <avlStatus xml:lang="EN">Oral and posted communication at the hepatology congress (AFEF (French Association for the study of the liver), AASLD (American Association for the Study of Liver Diseases), JFHOD (French-Speaking Days on Hepato-Gastroenterology and Digestive Oncology)), infectiology (RICAI (Interdisciplinary Meeting on Anti-Infective Chemotherapy)), pharmaco-economics, pharmaco-epidemiology</avlStatus>
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      <relPubl xml:lang="FR">http://www.ncbi.nlm.nih.gov/pubmed/?term=Pinta+A[author]+AND+hepatys</relPubl>
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