{
  "FullStudy":{
    "Rank":218261,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510626",
          "NCTIdAliasList":{
            "NCTIdAlias":[
              "NCT02062814"
            ]
          },
          "OrgStudyIdInfo":{
            "OrgStudyId":"22872"
          },
          "Organization":{
            "OrgFullName":"Stanford University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center",
          "OfficialTitle":"Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"April 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2015",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"November 29, 2011",
          "StudyFirstSubmitQCDate":"January 11, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 9, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 10, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Kari Christine Nadeau",
            "ResponsiblePartyInvestigatorTitle":"Associate Professor",
            "ResponsiblePartyInvestigatorAffiliation":"Stanford University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Stanford University",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The long-term goal of the investigators study is to develop a better and safer treatment for, and to potentially cure patients with single or multiple food allergies. The investigators hypothesize that the application of this protocol will allow patients with severe and single or multiple food allergies to be safely and rapidly desensitized."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Immune System Diseases"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Multiple food allergies"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"35",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"One",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Dietary Supplement: Food proteins",
                    "Drug: Omalizumab"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Dietary Supplement",
                "InterventionName":"Food proteins",
                "InterventionDescription":"Food proteins",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "One"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Omalizumab",
                "InterventionDescription":"Drug",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "One"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Number of adverse events in the treatment population",
                "PrimaryOutcomeTimeFrame":"2 years"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Number of subjects who reach 2g or more of food flour",
                "SecondaryOutcomeTimeFrame":"2 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nModerate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old.\nSensitivity to food allergen will be documented by a positive skin prick test result or allergen-specific ImmunoCAP IgE level, with 7 kU/L as a lower limit of eligibility.\n\nExclusion Criteria:\n\nNo absolute contraindications are known. However, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers).\nSubjects with a total IgE at screening of >2,000 kU/L\nPrevious reaction to omalizumab\nSubjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"4 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Stanford University School of Medicine",
                "LocationCity":"Stanford",
                "LocationState":"California",
                "LocationZip":"94305",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"29296107",
                "ReferenceType":"derived",
                "ReferenceCitation":"Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab. Allergy Asthma Clin Immunol. 2017 Dec 21;13:51. doi: 10.1186/s13223-017-0223-8. eCollection 2017."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000069444",
                "InterventionMeshTerm":"Omalizumab"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000018926",
                "InterventionAncestorTerm":"Anti-Allergic Agents"
              },{
                "InterventionAncestorId":"D000018927",
                "InterventionAncestorTerm":"Anti-Asthmatic Agents"
              },{
                "InterventionAncestorId":"D000019141",
                "InterventionAncestorTerm":"Respiratory System Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M413",
                "InterventionBrowseLeafName":"Omalizumab",
                "InterventionBrowseLeafAsFound":"Omalizumab",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M19546",
                "InterventionBrowseLeafName":"Anti-Allergic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19547",
                "InterventionBrowseLeafName":"Anti-Asthmatic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19721",
                "InterventionBrowseLeafName":"Respiratory System Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"AAll",
                "InterventionBrowseBranchName":"Anti-Allergic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"Resp",
                "InterventionBrowseBranchName":"Respiratory System Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006967",
                "ConditionMeshTerm":"Hypersensitivity"
              },{
                "ConditionMeshId":"D000005512",
                "ConditionMeshTerm":"Food Hypersensitivity"
              },{
                "ConditionMeshId":"D000007154",
                "ConditionMeshTerm":"Immune System Diseases"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000006969",
                "ConditionAncestorTerm":"Hypersensitivity, Immediate"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8601",
                "ConditionBrowseLeafName":"Hypersensitivity",
                "ConditionBrowseLeafAsFound":"Allergy",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M7219",
                "ConditionBrowseLeafName":"Food Hypersensitivity",
                "ConditionBrowseLeafAsFound":"Food Allergy",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8783",
                "ConditionBrowseLeafName":"Immune System Diseases",
                "ConditionBrowseLeafAsFound":"Immune System Diseases",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8603",
                "ConditionBrowseLeafName":"Hypersensitivity, Immediate",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}