NCT03569514

Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax

An Observational Clinical Study of AIGIV Use in Sporadic Cases of Systemic Anthrax

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a post-marketing requirement from the FDA to evaluate safety and clinical benefit of AIGIV administered to systemic anthrax patients as part of their medical care after exposure to Bacillus anthracis (anthrax exposure can be via inhalation, ingestion, injection). Study information (i.e. data on safety and clinical benefit evaluation of AIGIV up to Day 30 following administration) and patient samples (for assessment of AIGIV pharmacokinetics and anthrax toxin levels) will be collected (up to Day 7 following AIGIV administration) prospectively to the extent possible; however, in some cases data may be collected retrospectively (including scavenged patient samples for assessment of serum AIGIV concentration and anthrax toxin levels). Therefore, both prospective and retrospective data collection are allowed in this study to maximize the amount of information obtained from systemic anthrax patients who have been treated with AIGIV.

Conditions

• Anthrax

Interventions

Type	Name	Description
DRUG	AIGIV	Anthrax Immune Globulin Intravenous (Human)

Timeline

• Start date: 2026-11-30
• Primary completion: 2027-07-01
• Completion: 2027-08-01
• First posted: 2018-06-26
• Last updated: 2026-02-06

Regulatory

• FDA-regulated drug study