{
  "FullStudy":{
    "Rank":217937,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514890",
          "OrgStudyIdInfo":{
            "OrgStudyId":"ANRS CO20"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"2010-A01273-36",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"AFSSAPS"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)",
            "OrgClass":"OTHER_GOV"
          },
          "BriefTitle":"French Cohort of Therapeutic Failure and Resistances in Patients Treated With a Protease Inhibitor (Telaprevir or Boceprevir), Pegylated Interferon and Ribavirin",
          "OfficialTitle":"Cohort of Therapeutic Failure and Resistances in Patients Treated With a Protease Inhibitor (Telaprevir or Boceprevir), Pegylated Interferon (PEG-IFN) and Ribavirin (RBV) Included in the French Early Access Program for the Use of Protease Inhibitors in Genotype 1 Patients Who Failed to Eradicate HCV With a Previous Standard PEG-IFN and RBV Combination.",
          "Acronym":"CUPIC"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2017",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2011",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 23, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 24, 2017",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)",
            "LeadSponsorClass":"OTHER_GOV"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose fo the study is to evaluate the efficacy defined by the sustained virological response (SVR), in patients with compensated cirrhosis treated with PEG-IFN, RBV and telaprevir or boceprevir in the French Early Access Program for the use of protease inhibitors or after the approval of these drugs through the the marketing authorization.",
          "DetailedDescription":"Methodology: Multicentric French national cohort with prospective collection of data and constitution of biobank, in HCV genotype 1 patients with compensated cirrhosis who failed to eradicate HCV with the combination PEG-IFN and RBV, treated with protease inhibitor (telaprevir or boceprevir), PEG-IFN and RBV, included in the French Early Access Program for the use of protease inhibitors or after approval of these drugs through the the marketing authorization.\n\nPrimary objective: Evaluate the efficacy defined by the sustained virological response (SVR), in patients with compensated cirrhosis treated with PEG-IFN, RBV and telaprevir or boceprevir in the French Early Access Program for the use of protease inhibitors or after the approval of these drugs.\n\nEstimated enrollment: 900 patients treated in the French Early Access Program for the use of protease inhibitors and after the marketing authorization approval.\n\nTreatments:\n\nwith telaprevir: triple combination with PEG-IFN alfa-2a, 180 µg/week, ribavirin 1000 to 1200 mg/d according the body weight and telaprevir 750 mg/8h, for 12 weeks followed by PEG-IFN and RBV for 36 weeks for a total duration of treatment of 48 weeks.\nor with boceprevir: triple combination with PEG-IFN alfa-2b, 1,5 µg/kg/week, RBV 800 to 1400 mg/d according the body weight and boceprevir 800 mg/8h. The treatment will begin after a lead in phase of PEG-IFN and RBV for 4 weeks, followed by a triple combination (PEG-IFN, RBV and boceprevir)during 44 weeks for a total duration of treatment of 48 weeks.\n\nEstimated planning:\n\nstudy start date: February 2011\nenrollment period: 14 months\nsubject participation duration: 12 months of treatment and 12 months of follow-up = 24 months\ntotal study duration: 38 months. The last visit of the last enrolled patient is prevised in February 2014, the end of analysis on biobank in May 2014 (long term follow up of resistant mutants).\n\nSome blood samples will be preserved for scientific future research.\n\nStudy design: national French multicentric cohort in patients with HCV-related cirrhosis treated in the French Early Access Program for the use of boceprevir or telaprevir or after the marketing authorization approval of these drugs associated with PEG-IFN and RBV with a collection of clinical and biological data and constitution of a biobank."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Chronic Hepatitis C"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Other"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"whole blood"
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"675",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Telaprevir"
              },{
                "ArmGroupLabel":"Boceprevir"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Rate of sustained virological response (SVR) defined by an undetectable RNA by real-time PCR.",
                "PrimaryOutcomeTimeFrame":"6 months after discontinuation of therapy (at week 72)"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Virological response during and after the treatment with determination of HCV RNA levels as prevised by the French Early Access Program for the use of protease inhibitors and after the approval.",
                "SecondaryOutcomeDescription":"This will allow to define:\n\nrate of non response (detectable RNA during the treatment)\nrate of virological breakthrough (undetectable HCV RNA then detectable during the treatment)\nrate of virological relapse after the discontinuation of treatment (undetectable HCV RNA at the end of therapy then detectable after the treatment)",
                "SecondaryOutcomeTimeFrame":"at D0, W4, W8, W12, W24, W48 and 12 (W60) and 24 (W72) weeks after the discontinuation of treatment"
              },{
                "SecondaryOutcomeMeasure":"early viral kinetic",
                "SecondaryOutcomeTimeFrame":"at the D0, W1, W2 and W4"
              },{
                "SecondaryOutcomeMeasure":"Rate of premature discontinuation of protease inhibitor, RBV and/or PEG-IFN",
                "SecondaryOutcomeTimeFrame":"in may 2014 (3 month after study completion date)"
              },{
                "SecondaryOutcomeMeasure":"occurrence of resistant mutants in partial responders (detectable RNA) or after the occurrence of virological breakthrough and long term evolution of these mutations (on serum bank)",
                "SecondaryOutcomeTimeFrame":"in may 2014 (3 month after study completion date)"
              },{
                "SecondaryOutcomeMeasure":"Evolution of quality of life scores",
                "SecondaryOutcomeTimeFrame":"in may 2014 (3 month after study completion date)"
              },{
                "SecondaryOutcomeMeasure":"Evaluation of therapeutic observance with auto-questionnaires",
                "SecondaryOutcomeTimeFrame":"in may 2014 (3 month after study completion date)"
              },{
                "SecondaryOutcomeMeasure":"Rate of adaptation of dosage of protease inhibitors, RBV and/or PEG-IFN",
                "SecondaryOutcomeTimeFrame":"in may 2014 (3 month after study completion date)"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\npatients who need the criteria of French Early Access Program for boceprevir and telaprevir or after the marketing authorization approval:\n\npatients aged of 18 years or more with chronic hepatitis C\nrelapsers or partial-responders or null-responders to treatment with PEG'IFN α2a or 2b associated or not with RBV\nchronic infection with genotype 1 HCV\nfibrosis Metavir score of 4 (cirrhosis)\nwithout decompensated liver disease\nnaïve of direct anti-viral treatment\nwithout HIV or HBV co-infection\nsignature of participation to the cohort",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Patients with chronic hepatitis C in genotype 1 Who Failed to Eradicate HCV With a Previous Standard PEG-IFN and RBV Combination",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Christophe HEZODE",
                "OverallOfficialAffiliation":"GHU H. Mondor",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Fabrice CARRAT, Methodologist",
                "OverallOfficialAffiliation":"Unité INSERM 707",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Hôpital Henri Mondor",
                "LocationCity":"Créteil",
                "LocationZip":"94000",
                "LocationCountry":"France"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"25556540",
                "ReferenceType":"derived",
                "ReferenceCitation":"Sultanik P, Mallet V, Lagaye S, Casrouge A, Dorival C, Barthe Y, Fontaine H, Hézode C, Mottez E, Bronowicki JP, Carrat F, Theodorou I, Abel L, Gayat E, Fontanet A, Pol S, Albert ML; ANRS CO20-CUPIC. Plasma apolipoprotein H limits HCV replication and associates with response to NS3 protease inhibitors-based therapy. Liver Int. 2015 Jul;35(7):1833-44. doi: 10.1111/liv.12759. Epub 2015 Jan 23."
              },{
                "ReferencePMID":"24704719",
                "ReferenceType":"derived",
                "ReferenceCitation":"Hézode C, Fontaine H, Dorival C, Zoulim F, Larrey D, Canva V, De Ledinghen V, Poynard T, Samuel D, Bourliere M, Alric L, Raabe JJ, Zarski JP, Marcellin P, Riachi G, Bernard PH, Loustaud-Ratti V, Chazouilleres O, Abergel A, Guyader D, Metivier S, Tran A, Di Martino V, Causse X, Dao T, Lucidarme D, Portal I, Cacoub P, Gournay J, Grando-Lemaire V, Hillon P, Attali P, Fontanges T, Rosa I, Petrov-Sanchez V, Barthe Y, Pawlotsky JM, Pol S, Carrat F, Bronowicki JP; CUPIC Study Group. Effectiveness of telaprevir or boceprevir in treatment-experienced patients with HCV genotype 1 infection and cirrhosis. Gastroenterology. 2014 Jul;147(1):132-142.e4. doi: 10.1053/j.gastro.2014.03.051. Epub 2014 Apr 3."
              },{
                "ReferencePMID":"23669289",
                "ReferenceType":"derived",
                "ReferenceCitation":"Hézode C, Fontaine H, Dorival C, Larrey D, Zoulim F, Canva V, de Ledinghen V, Poynard T, Samuel D, Bourlière M, Zarski JP, Raabe JJ, Alric L, Marcellin P, Riachi G, Bernard PH, Loustaud-Ratti V, Métivier S, Tran A, Serfaty L, Abergel A, Causse X, Di Martino V, Guyader D, Lucidarme D, Grando-Lemaire V, Hillon P, Feray C, Dao T, Cacoub P, Rosa I, Attali P, Petrov-Sanchez V, Barthe Y, Pawlotsky JM, Pol S, Carrat F, Bronowicki JP; CUPIC Study Group. Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC) - NCT01514890. J Hepatol. 2013 Sep;59(3):434-41. doi: 10.1016/j.jhep.2013.04.035. Epub 2013 May 10."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006526",
                "ConditionMeshTerm":"Hepatitis C"
              },{
                "ConditionMeshId":"D000019698",
                "ConditionMeshTerm":"Hepatitis C, Chronic"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000006505",
                "ConditionAncestorTerm":"Hepatitis"
              },{
                "ConditionAncestorId":"D000008107",
                "ConditionAncestorTerm":"Liver Diseases"
              },{
                "ConditionAncestorId":"D000004066",
                "ConditionAncestorTerm":"Digestive System Diseases"
              },{
                "ConditionAncestorId":"D000006525",
                "ConditionAncestorTerm":"Hepatitis, Viral, Human"
              },{
                "ConditionAncestorId":"D000014777",
                "ConditionAncestorTerm":"Virus Diseases"
              },{
                "ConditionAncestorId":"D000018178",
                "ConditionAncestorTerm":"Flaviviridae Infections"
              },{
                "ConditionAncestorId":"D000012327",
                "ConditionAncestorTerm":"RNA Virus Infections"
              },{
                "ConditionAncestorId":"D000006521",
                "ConditionAncestorTerm":"Hepatitis, Chronic"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8174",
                "ConditionBrowseLeafName":"Hepatitis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8175",
                "ConditionBrowseLeafName":"Hepatitis A",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8194",
                "ConditionBrowseLeafName":"Hepatitis C",
                "ConditionBrowseLeafAsFound":"Hepatitis C",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M20197",
                "ConditionBrowseLeafName":"Hepatitis C, Chronic",
                "ConditionBrowseLeafAsFound":"Chronic Hepatitis C",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8190",
                "ConditionBrowseLeafName":"Hepatitis, Chronic",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9690",
                "ConditionBrowseLeafName":"Liver Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7466",
                "ConditionBrowseLeafName":"Gastrointestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5838",
                "ConditionBrowseLeafName":"Digestive System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8193",
                "ConditionBrowseLeafName":"Hepatitis, Viral, Human",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16105",
                "ConditionBrowseLeafName":"Virus Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M18907",
                "ConditionBrowseLeafName":"Flaviviridae Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13732",
                "ConditionBrowseLeafName":"RNA Virus Infections",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC02",
                "ConditionBrowseBranchName":"Viral Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              }
            ]
          }
        }
      }
    }
  }
}