A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients
Launched by EMERGENT BIOSOLUTIONS · Jun 15, 2018
Trial Information
Current as of May 01, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is designed to study the safety and effectiveness of a treatment called AIGIV (ANTHRASIL®) for patients who have inhalational anthrax, a serious illness caused by exposure to anthrax bacteria. The trial will only take place if there is a significant anthrax exposure event, and its main goal is to gather information about how well AIGIV works in helping patients recover from the illness, how safe it is, and to measure the levels of AIGIV and anthrax toxins in the patients' bodies.
To be eligible to participate, individuals must have confirmed or suspected inhalational anthrax linked to a known exposure scenario and must agree to receive treatment with AIGIV. There are no specific exclusions for participants in this study. If someone is involved in the trial, they can expect to receive AIGIV and be closely monitored for their health and recovery. This study is important because it aims to improve treatment options and understanding of inhalational anthrax in critical situations.
Gender
ALL
Eligibility criteria
- 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.
About Emergent Biosolutions
Emergent BioSolutions is a global biopharmaceutical company dedicated to providing specialized products and solutions to address public health threats and enhance patient care. With a strong focus on developing and commercializing vaccines and therapeutics for infectious diseases, Emergent leverages its expertise in biotechnology and manufacturing to deliver innovative medical countermeasures. The company is committed to advancing clinical research and trials, ensuring the safety and efficacy of its products while collaborating with government and private sectors to respond effectively to emerging health challenges. Through its dedication to science and community health, Emergent BioSolutions aims to make a meaningful impact on global health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Brandon Essink, MD
Principal Investigator
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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