Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax
NCT03569514 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 10
Last updated 2026-02-06
Summary
This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with systemic anthrax. 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 sporadic cases of systemic anthrax patients treated with AIGIV.
Conditions
- 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
- 2026-11-30
- Primary Completion
- 2027-07-31
- Completion
- 2027-08-31
- FDA Drug
- Yes
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