[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100311289":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":25,"locations":33,"responsibleParty":73,"collaborators":25,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":25,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":25,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":25,"overallStatus":95,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lumicitabine","EXPERIMENTAL","Participants who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received a regimen containing lumicitabine for the treatment of RSV infection, and who agree to participate in this follow-up study will be assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of lumicitabine, frequency and type of respiratory infections and medical resource usage.",[13],"Drug: Lumicitabine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received a regimen containing placebo for the treatment of RSV infection, and who agree to participate in this follow-up study will be assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of placebo, frequency and type of respiratory infections and medical resource usage.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.",[15],[30],{"name":31,"affiliation":5,"role":32},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[34,46,55,64],{"facility":35,"status":25,"city":36,"state":25,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":25},"Fukuyama City Hospital","Fukuyama","721-8511","Japan","JP",{"type":41,"coordinates":42},"Point",[43,44],133.36667,34.48333,{"lat":44,"lon":43},{"facility":47,"status":25,"city":48,"state":25,"zip":49,"country":38,"countryCode":39,"cosmosGeoPoint":50,"geoPoint":54,"contacts":25},"Hirosaki National Hospital","Hirosaki","036-8545",{"type":41,"coordinates":51},[52,53],140.4725,40.59306,{"lat":53,"lon":52},{"facility":56,"status":25,"city":57,"state":25,"zip":58,"country":38,"countryCode":39,"cosmosGeoPoint":59,"geoPoint":63,"contacts":25},"National Hospital Organization Niigata National Hospital","Niigata","945-8585",{"type":41,"coordinates":60},[61,62],139.04125,37.92259,{"lat":62,"lon":61},{"facility":65,"status":25,"city":66,"state":25,"zip":67,"country":38,"countryCode":39,"cosmosGeoPoint":68,"geoPoint":72,"contacts":25},"National Hospital Organization Beppu Medical Center","Ōita","874-0011",{"type":41,"coordinates":69},[70,71],131.6,33.23333,{"lat":71,"lon":70},{"type":74,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100311289","phase-2-a-long-term-follow-up-study-to-evaluate-the-impact-of-lumicitabine-on-the-incidence-of-asthma-andor-wheezing-in-infants-and-children-with-a-history-of-respiratory-syncytial-virus-infection-100311289",true,"NCT03332459","A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and\u002For Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection","A Long-term Follow-up of Study 64041575RSV2004 to Evaluate the Impact of Lumicitabine (JNJ-64041575) on the Incidence of Asthma and\u002For Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection","Inclusion Criteria:\n\n* Male or female infants and children who were previously randomized in study 64041575RSV2004 for the treatment of respiratory syncytial virus (RSV) infection and who completed the planned course of the study drug and the last study-related visit of study 64041575RSV2004\n* The participant's legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing for the participant to participate in the study\n\nExclusion Criteria:\n\n* The participants legally acceptable representative, i.e, parent\u002Flegal guardian\u002Fcaregiver, is not able to maintain reliable communication with the investigator\n* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments",false,"ALL","56 Days","39 Months",{"count":87,"type":88},7,"ACTUAL","INTERVENTIONAL",[91],"PHASE2","The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the clinical diagnosis of asthma and the frequency of wheezing in infants and children with respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo) and have completed their last planned study-related visit in a feeding Phase 2 study (64041575RSV2004).",[94],"Respiratory Syncytial Virus Infections","COMPLETED","2021-03-18",{"date":98,"type":88},"2021-04-13",{"date":100,"type":88},"2018-01-05",{"date":102,"type":88},"2020-04-13",{"name":5,"class":6},4]