[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509073":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":45,"collaborators":47,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":10,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":63,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Scynexis, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Cohort",null,"Subjects who have been treated with Brexafemme (Ibrexafungerp) at any time during pregnancy or whose conception is estimated to have occurred within four days after receiving the last dose of Brexafemme.",[13],"Other: Non-interventional study",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"OTHER","Non-interventional study","This is not an interventional study",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Sanjeev Miglani, MD","CONTACT","+91-9910533655","sanjeev.miglani@awinsals.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"AWINSA","RECRUITING","New Delhi","Vasant Vihar","110057","India","IN",{"type":36,"coordinates":37},"Point",[38,39],77.2148,28.62137,{"lat":39,"lon":38},[42,43],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"name":22,"role":44,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":46,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[48],{"name":28,"class":49},"UNKNOWN","100509073","safety-of-pregnant-subjects-exposed-to-ibrexafungerp-including-infant-outcomes-100509073",false,"NCT05908682","Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes","A Single-arm Safety Study of Subjects Exposed to Ibrexafungerp Whilst Pregnant, Including Infant Outcomes Up to One Year","Inclusion Criteria:\n\n1. Exposure to ibrexafungerp during pregnancy or if conception is estimated to have occurred within 4 days of the last dose of ibrexafungerp\n2. Subject and\u002For parent\u002Flegal representative consents to participate and agrees to the conditions and requirements of the study including the interview schedule\u002Fcompletion of questionnaire and release of medical records\n\n   * Subject can be identified by the sponsor or HCP, in terms of confirmed pregnancy.\n\nA self-reported pregnancy will be considered as confirmed pregnancy if the Urine Pregnancy Test (UPT) result is positive.\n\n* A woman can self-enroll in the study or her healthcare provider (HCP), with her consent, can enroll her on her behalf.\n\nExclusion Criteria:\n\n1. Females who were not exposed to safety study medications during pregnancy\n2. Refusal to participate in the study\n3. An inability to provide an accurate medical history or give informed consent",true,"FEMALE","0 Years",{"count":61,"type":62},100,"ESTIMATED","1 Year","OBSERVATIONAL","This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.",[67,68,69],"Vulvovaginal Candidiasis","Candida Infection","Vaginal Candidiasis",[71,72,73,74,75,76],"VVC","Thrush","BREXAFEMME","Candidiasis","Vaginal Yeast","Yeast Infection","2024-07-15",{"date":79,"type":80},"2024-07-17","ACTUAL",{"date":82,"type":80},"2022-07-28",{"date":84,"type":62},"2029-10-31",{"name":5,"class":6},1]