{
  "FullStudy":{
    "Rank":217751,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517308",
          "OrgStudyIdInfo":{
            "OrgStudyId":"C.E. Federico II 47/11"
          },
          "Organization":{
            "OrgFullName":"Federico II University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"24 VS 48-WEEK TREATMENT WITH PEG-IFN ALPHA-2A IN PATIENTS WITH GENOTYPE 2/3 CHRONIC HEPATITIS C",
          "OfficialTitle":"24 VS 48-WEEK TREATMENT WITH PEG-IFN ALPHA-2A IN PATIENTS WITH GENOTYPE 2/3 CHRONIC HEPATITIS C, RELAPSERS TO PEG-IFN + RIBAVIRIN TREATMENT. A RANDOMIZED CONTROLLED TRIAL"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2012",
          "OverallStatus":"Withdrawn",
          "WhyStopped":"Time elapsed to require permissions and a recent paper showed a high efficacy of a 48-week regimen in this setting. It seems non-ethical to start this trial",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"May 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2015",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2015",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 16, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 19, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Prof. Guglielmo Borgia",
            "ResponsiblePartyInvestigatorTitle":"Full Professor",
            "ResponsiblePartyInvestigatorAffiliation":"Federico II University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Federico II University",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Aim of the present study is to evaluate in a cohort of patients with genotype 2/3 chronic hepatitis C, relapsers to a previous PEG-IFN + ribavirin therapy (alpha-2a or alpha-2b) the efficacy of PEG-IFNα-2a + ribavirin administered for 24 or 48 weeks. It will be evaluated whether 48 weeks of therapy may achieve better results compared to the standard duration (24 weeks)."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Chronic Hepatitis C"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "HCV",
              "Hepatitis",
              "Genotype 2 or 3",
              "Pegylated Interferon",
              "Duration"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"0",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Control Arm 24 weeks",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"PEG-IFN α2a 180 μg/week+ ribavirin 800 mg/die for 24 weeks",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: pegylated interferon alpha 2a + ribavirin"
                  ]
                }
              },{
                "ArmGroupLabel":"Active arm (48 weeks)",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"PEG-IFN α2a 180 μg/week + ribavirin 800 mg/die per 48 weeks",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: pegylated interferon alpha 2a + ribavirin"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"pegylated interferon alpha 2a + ribavirin",
                "InterventionDescription":"Comparison of different duration of drugs (48 weeks vs. 24 weeks)",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Active arm (48 weeks)",
                    "Control Arm 24 weeks"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Sustained virological response (SVR)",
                "PrimaryOutcomeDescription":"HCV-RNA undetectability (by the means of Real time PCR assay with a sensitivity limit of 20 UI/mL) 6 months after therapy withdrawal.",
                "PrimaryOutcomeTimeFrame":"6 months after therapy withdrawal"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nWritten informed consent\nAge more than 18 years\nCompensated liver disease with following pre-enrollment hematological parameters: Hemoglobin more than 13 g/dl in males and 12 g/dl in females; White blood cell count more than 3,000/mmc; Platelet count more than 100,000 /mmc\nAnti-nuclear antibodies (ANA) less than 1:160\nAnti-Liver-Kidney antibodies (LKM1): negative\nalpha1 fetoprotein levels less than 50 ng/ml in 3 months before enrollment and liver Ultrasound negative for focal malignant lesions.\nHBsAg: negative\nClinical or histological diagnosis of chronic hepatitis C\nHCV-RNA: positive\nRelapse (end-of-treatment HCV-RNA negativity and positivization within 6 months after therapy withdrawal) to at-least one previous treatment of PEG-IFN (alpha2a or alpha2b) + ribavirin which should have lasted at least for 80% of the 24 planned weeks with at least 80% of total planned dose of PEG-IFN and ribavirin administered.\nNormal values of total and direct bilirubin (with the exception of indirect bilirubin due to extrahepatic factors such as Gilbert syndrome; in these cases the levels should be less than 3 mg/dL).\nNormal values of albumin and creatinin\nNormal fasting glycemia or, in case of glycemic values between 115mg/dL and 140 mg/dl (values confirmed in more than one determination) or if the patient is affected by diabetes mellitus, glycated hemoglobin should be < 8,5%.\nNormal Thyroid Stimulating Hormone (TSH) level. Subjects under pharmacological treatment to maintain normal TSH levels can be enrolled if they fulfill other criteria.\nIn case of history of diabetes or hypertension a specialist examination is required to rule out contraindication to therapy.\nAdoption of contraceptive measures\n\nExclusion Criteria:\n\nAge less than 18 years\nWomen during pregnancy or breast-feeding\nPrevious treatment with PEG-IFN alpha2a or alpha2b + ribavirin for more than 6 months\nParticipation to any clinical trial within 30 days from enrollment in this protocol\nSubjects with solid organ transplantation (with the exception of cornea or hair transplantation)\nSubject not willing to have a counseling or to abstain from alcohol use\nSuspected hypersensitivity to PEG-Interferon alpha2a or ribavirin\nAny other cause of liver disease different from chronic hepatitis C based on anamnesis of patient or on histological evidence including but not limited to:\nHBV coinfection\nAlpha-1 antitrypsin deficiency\nWilson disease\nAutoimmune hepatitis\nAlcoholic liver disease\nHemoglobinopathy included but not limited to thalassemia major.\nAdvanced liver diseases diagnosed through history or presence of ascites, esophageal variceal bleeding or hepatic encephalopathy\nPsychiatric conditions: depression or medical history of severe psychiatric alterations such as major psychosis, suicidal ideas, suicidal attempts, depression that required hospitalization or electroconvulsive therapy, prolonged work leave or significant impairment of everyday activities should be excluded. Subjects with history of slight depression might be considered for enrollment in the study if a pre-treatment psychiatric evaluation indicates that the subject is stable and that is possible to follow its mental status during the study.\nCentral nervous system trauma or convulsive status requiring treatment.\nCardiovascular diseases (e.g. angina, congestive heart disease, myocardial infarction, major arrhythmias).\nDecompensated diabetes mellitus\nClinical gout\nChronic pulmonary diseases\nImmune-mediated diseases (e.g. chronic inflammatory bowel diseases, idiopathic thrombocytopenic purpura, Systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis)\nAbuse of substances such as alcohol (more than 80 g/die), i.v. or inhalator drugs. Subjects with a history of drug abuse can be enrolled if they were abstinent for at least 2 years.\nSubjects with clinically relevant retinal lesions\nAny other condition that at investigators opinion could be a reason of non suitability for patients or can interfere with his/her participation to the study.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Guglielmo Borgia, Professor",
                "OverallOfficialAffiliation":"Federico II University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University of Naples Federico II",
                "LocationCity":"Naples",
                "LocationZip":"I-80131",
                "LocationCountry":"Italy"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"17625124",
                "ReferenceType":"background",
                "ReferenceCitation":"Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Solá R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000007372",
                "InterventionMeshTerm":"Interferons"
              },{
                "InterventionMeshId":"D000012254",
                "InterventionMeshTerm":"Ribavirin"
              },{
                "InterventionMeshId":"D000016898",
                "InterventionMeshTerm":"Interferon-alpha"
              },{
                "InterventionMeshId":"D000077190",
                "InterventionMeshTerm":"Interferon alpha-2"
              },{
                "InterventionMeshId":"C000100416",
                "InterventionMeshTerm":"Peginterferon alfa-2a"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              },{
                "InterventionAncestorId":"D000000998",
                "InterventionAncestorTerm":"Antiviral Agents"
              },{
                "InterventionAncestorId":"D000000890",
                "InterventionAncestorTerm":"Anti-Infective Agents"
              },{
                "InterventionAncestorId":"D000000963",
                "InterventionAncestorTerm":"Antimetabolites"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000007155",
                "InterventionAncestorTerm":"Immunologic Factors"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M13666",
                "InterventionBrowseLeafName":"Ribavirin",
                "InterventionBrowseLeafAsFound":"Ribavirin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M8990",
                "InterventionBrowseLeafName":"Interferons",
                "InterventionBrowseLeafAsFound":"Interferon",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M17826",
                "InterventionBrowseLeafName":"Interferon-alpha",
                "InterventionBrowseLeafAsFound":"Interferon alfa-",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M1685",
                "InterventionBrowseLeafName":"Interferon alpha-2",
                "InterventionBrowseLeafAsFound":"Interferon alfa-2",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M255637",
                "InterventionBrowseLeafName":"Peginterferon alfa-2a",
                "InterventionBrowseLeafAsFound":"Pegylated interferon alfa-2a",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2895",
                "InterventionBrowseLeafName":"Antiviral Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2795",
                "InterventionBrowseLeafName":"Anti-Infective Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2862",
                "InterventionBrowseLeafName":"Antimetabolites",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8784",
                "InterventionBrowseLeafName":"Immunologic Factors",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic Agents"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006506",
                "ConditionMeshTerm":"Hepatitis A"
              },{
                "ConditionMeshId":"D000006526",
                "ConditionMeshTerm":"Hepatitis C"
              },{
                "ConditionMeshId":"D000019698",
                "ConditionMeshTerm":"Hepatitis C, Chronic"
              },{
                "ConditionMeshId":"D000006505",
                "ConditionMeshTerm":"Hepatitis"
              },{
                "ConditionMeshId":"D000006521",
                "ConditionMeshTerm":"Hepatitis, Chronic"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000008107",
                "ConditionAncestorTerm":"Liver Diseases"
              },{
                "ConditionAncestorId":"D000004066",
                "ConditionAncestorTerm":"Digestive System Diseases"
              },{
                "ConditionAncestorId":"D000006525",
                "ConditionAncestorTerm":"Hepatitis, Viral, Human"
              },{
                "ConditionAncestorId":"D000014777",
                "ConditionAncestorTerm":"Virus Diseases"
              },{
                "ConditionAncestorId":"D000004769",
                "ConditionAncestorTerm":"Enterovirus Infections"
              },{
                "ConditionAncestorId":"D000010850",
                "ConditionAncestorTerm":"Picornaviridae Infections"
              },{
                "ConditionAncestorId":"D000012327",
                "ConditionAncestorTerm":"RNA Virus Infections"
              },{
                "ConditionAncestorId":"D000018178",
                "ConditionAncestorTerm":"Flaviviridae Infections"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8174",
                "ConditionBrowseLeafName":"Hepatitis",
                "ConditionBrowseLeafAsFound":"Hepatitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8175",
                "ConditionBrowseLeafName":"Hepatitis A",
                "ConditionBrowseLeafAsFound":"Hepatitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "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",
                "ConditionBrowseLeafAsFound":"Chronic Hepatitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "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":"M6513",
                "ConditionBrowseLeafName":"Enterovirus Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M12328",
                "ConditionBrowseLeafName":"Picornaviridae Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13732",
                "ConditionBrowseLeafName":"RNA Virus Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M18907",
                "ConditionBrowseLeafName":"Flaviviridae 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"
              }
            ]
          }
        }
      }
    }
  }
}