Clinical Trial

A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients

Not Yet Recruiting
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Summary
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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2018-06-15; most recent amendment 2026-02-04.
Trial Details
NCT Number NCT03569553
Lead Sponsor Emergent BioSolutions
Collaborators: Centers for Disease Control and Prevention, Department of Health and Human Services
Conditions Inhalational Anthrax
Enrollment 100 participants
Start Date 2027-05-30
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-02-06