{
  "FullStudy":{
    "Rank":218014,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513850",
          "OrgStudyIdInfo":{
            "OrgStudyId":"Hepabulin IV_LT_lll_2011"
          },
          "Organization":{
            "OrgFullName":"SK Chemicals Co., Ltd.",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients",
          "OfficialTitle":"A 52-week, Multi-center, Open Label, Single Arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients"
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 29, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"June 1, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"SK Chemicals Co., Ltd.",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.",
          "DetailedDescription":"A 52-week, Multi-center, Open label, Single arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg positive Liver Transplantation recipients"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Hepatitis B"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Liver Transplantation",
              "HBV",
              "HBV Recurrence",
              "HBsAg Positive"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"87",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Hepabulin IV",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Hepabulin IV"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Hepabulin IV",
                "InterventionDescription":"I.V.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Hepabulin IV"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"HBV(HBsAg) recurrence",
                "PrimaryOutcomeTimeFrame":"52 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Time to recurrence",
                "SecondaryOutcomeTimeFrame":"52 weeks"
              },{
                "SecondaryOutcomeMeasure":"Survival",
                "SecondaryOutcomeTimeFrame":"52 weeks"
              },{
                "SecondaryOutcomeMeasure":"viral Marker of HBV",
                "SecondaryOutcomeTimeFrame":"52 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHBsAg Positive candidate for HBV-related liver transplant\nPrimary, single organ recipients\nwritten informed consent\n\nExclusion Criteria:\n\nacute renal failure, Serum creatinin >1.5*ULN\nsevere cardiac disease or other significant disease\nHAV, HCV or HIV positive\nImmunoglobulin A deficiency.\nHistory of hypersensitivity to Human Immunoglobulin.\nHistory of cancer within 5 years. (without HCC)\nHistory of alcohol or/and drug abuse.\nHistory organ transplantation.\nWithin 30 days, participation in another clinical trial and use of an investigational product.\nSubject suffer from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that, may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of study result.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"64 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Dong Goo Kim, MD, PhD",
                "OverallOfficialAffiliation":"St.Mary's Hospital, Catholic University Medical college",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"SKChemicals",
                "LocationCity":"Seongnam",
                "LocationState":"Gyunggi-do",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006509",
                "ConditionMeshTerm":"Hepatitis B"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000006505",
                "ConditionAncestorTerm":"Hepatitis"
              },{
                "ConditionAncestorId":"D000008107",
                "ConditionAncestorTerm":"Liver Diseases"
              },{
                "ConditionAncestorId":"D000004066",
                "ConditionAncestorTerm":"Digestive System Diseases"
              },{
                "ConditionAncestorId":"D000018347",
                "ConditionAncestorTerm":"Hepadnaviridae Infections"
              },{
                "ConditionAncestorId":"D000004266",
                "ConditionAncestorTerm":"DNA Virus Infections"
              },{
                "ConditionAncestorId":"D000014777",
                "ConditionAncestorTerm":"Virus Diseases"
              },{
                "ConditionAncestorId":"D000006525",
                "ConditionAncestorTerm":"Hepatitis, Viral, Human"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8178",
                "ConditionBrowseLeafName":"Hepatitis B",
                "ConditionBrowseLeafAsFound":"Hepatitis B",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8174",
                "ConditionBrowseLeafName":"Hepatitis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13433",
                "ConditionBrowseLeafName":"Recurrence",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8175",
                "ConditionBrowseLeafName":"Hepatitis A",
                "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":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M19071",
                "ConditionBrowseLeafName":"Hepadnaviridae Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16105",
                "ConditionBrowseLeafName":"Virus Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6025",
                "ConditionBrowseLeafName":"DNA Virus Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8193",
                "ConditionBrowseLeafName":"Hepatitis, Viral, Human",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC02",
                "ConditionBrowseBranchName":"Viral Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              }
            ]
          }
        }
      }
    }
  }
}