A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients
NCT03569553 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2026-02-06
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.
Conditions
- Inhalational Anthrax
Interventions
- DRUG
-
AIGIV
Anthrax Immune Globulin Intravenous (Human)
Sponsors & Collaborators
-
Centers for Disease Control and Prevention
collaborator FED -
Department of Health and Human Services
collaborator FED -
Emergent BioSolutions
lead INDUSTRY
Principal Investigators
-
Brandon Essink, MD
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2027-05-30
- Primary Completion
- 2027-07-31
- Completion
- 2027-07-31
- FDA Drug
- Yes
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