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

Emergent BioSolutions

Status: Begins enrollment in 6 months

Conditions: Inhalational Anthrax

Treatments: Drug: AIGIV

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT03569553

AX-003A

Details and patient eligibility

About

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.

Full description

This study is a post-marketing requirement from the FDA to evaluate safety and clinical benefit of AIGIV administered to patients as part of their medical care after inhalational exposure to Bacillus anthracis. 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, due to logistical complexities that will likely occur during a mass anthrax exposure event, most data for this study will 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 inhalational anthrax patients who have been administered AIGIV.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed or suspected inhalational anthrax linked to an identified broad exposure scenario.
• Treatment with AIGIV.
• Informed consent/assent (as applicable).

Exclusion criteria

• There are no exclusion criteria for subjects enrolling in this study.

Trial design

100 participants in 1 patient group

AIGIV

Description:

Inhalational anthrax patients who have been administered AIGIV (ANTHRASIL®) as per licensed US prescribing information.

Treatment:

Drug: AIGIV