{"doc_desc":{"title":"Cohort of Liver Transplant Patients with Hepatitis C Recurrence Treated with Direct Acting Antiviral Agent","idno":"FRESH-PEF73116-en","producers":[{"name":"Georges-Philippe PAGEAUX","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73116-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73116"},{"agency":"FReSH","code":"FRESH-PEF73116"}]},"title":"Cohort of Liver Transplant Patients with Hepatitis C Recurrence Treated with Direct Acting Antiviral Agent","alternate_title":"ANRS CO23 CUPILT"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Audrey;COILLY","PILabo":"Paul Brousse Hepatobiliary Centre \/ Joint Research Unit U785","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"14463774X","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation 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hepatitis","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1469571641","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"To investigate the efficacy, defined as obtaining a sustained virology response after 12 weeks of completing treatment, of direct acting agents (DAA) with or without peginterferon and\/or ribavirin therapy, in liver transplant patients with Hepatitis C virus (HCV) infection recurrence following liver transplantation, regardless of genotype or response to previous treatment.","abstract":"","coll_dates":[{"start":"2013-01-01","end":"2022-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Belgium","abbreviation":"be","extLink":{"vocab":"ISO","vocabURI":"be"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n  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\"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"\u2013 elderly subjects over 18 years old  \u2013 transplanted liver  \u2013 infected with HCV before transplantation  \u2013 presenting Hepatitis C virus (HCV) infection recurrence (regardless of genotype) with detectable HCV RNA at baseline  \u2013 received or receiving antiviral therapy with a direct antiviral agent or having completed treatment but still being monitored (within 48 weeks after completing treatment)  \u2013 member of a social security scheme  \u2013 signed consent form   N.B.: Included  \u2013 multiple transplants  \u2013 treatment-naive or failed treatment patients, before and after transplantation, regardless of previous model  \u2013 patients with HIV or HBV co-infection  \u2013 all stages of hepatic fibrosis\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth 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