[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100329463":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":10,"responsibleParty":31,"collaborators":33,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":10,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":10,"maxAge":10,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":10},{"fullName":5,"class":6},"Emergent BioSolutions","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AIGIV",null,"Inhalational anthrax patients who have been administered AIGIV (ANTHRASIL®) as per licensed US prescribing information.",[13],"Drug: AIGIV",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Anthrax Immune Globulin Intravenous (Human)",[9],[20],"ANTHRASIL®",[22],{"name":23,"affiliation":10,"role":24},"Brandon Essink, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Clinical Development Representative","CONTACT","240-631-3200","ctgov@ebsi.com",{"type":32,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[34,37],{"name":35,"class":36},"Centers for Disease Control and Prevention","FED",{"name":38,"class":36},"Department of Health and Human Services","100329463","a-field-study-evaluating-clinical-benefit-and-safety-of-aigiv-anthrasil-in-inhalational-anthrax-patients-100329463",false,"NCT03569553","A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients","A Field Study for the Evaluation of AIGIV Clinical Benefit and Safety in the Treatment of Patients With Inhalational Anthrax in a Broad Exposure Event Scenario","Inclusion Criteria:\n\n* Confirmed or suspected inhalational anthrax linked to an identified broad exposure scenario.\n* Treatment with AIGIV.\n* Informed consent\u002Fassent (as applicable).\n\nExclusion Criteria:\n\n* There are no exclusion criteria for subjects enrolling in this study.","ALL",{"count":48,"type":49},100,"ESTIMATED","OBSERVATIONAL","This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with inhalational anthrax. This study will be implemented only in the event of a major anthrax exposure event. The study is designed to collect information on safety, clinical benefit (such as extent of anthrax illness and survival) and serum concentrations of AIGIV (for AIGIV pharmacokinetics) and anthrax toxins from inhalational anthrax patients treated with AIGIV.",[53],"Inhalational Anthrax",[55,56,57,58,9,59,60,61,62],"Anthrax","Bacillus anthracis","Inhalational anthrax","Bacterial infection","Anthrasil","Anthrax immune globulin","Anti toxin","Polyclonal antibodies","NOT_YET_RECRUITING","2026-02-04",{"date":66,"type":67},"2026-02-06","ACTUAL",{"date":69,"type":49},"2027-05-30",{"date":71,"type":49},"2027-07",{"name":5,"class":6}]