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

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary and study completion dates: Jul 2026 to Jul 2027
    • Start date: May 30, 2026 to May 30, 2027
    v14
  2. Start date: Feb 11, 2025 to May 30, 2026v13
  3. Re-verified, no change to tracked fieldsv12
  4. Primary and study completion dates: Jul 2025 to Jul 2026
    • Start date: Feb 11, 2024 to Feb 11, 2025
    v11
  5. Re-verified, no change to tracked fieldsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Start date: Feb 2023 to Feb 11, 2024v9
  2. Start date: Aug 2022 to Feb 2023v8
  3. Start date: Aug 2021 to Aug 2022v7
  4. Re-verified, no change to tracked fieldsv6
  5. Start date: Aug 2020 to Aug 2021v5
  6. Start date: Aug 2019 to Aug 2020v4
  7. Start date: Aug 2018 to Aug 2019v3
  8. Start date: Jul 2018 to Aug 2018
    • Study title shortened, about 2 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03569553
Lead Sponsor Emergent BioSolutions
Collaborators: Centers for Disease Control and Prevention, Department of Health and Human Services
Conditions
(from sponsor)		 Inhalational Anthrax
Related terms Anthrax, Bacterial Infections, Inhalation anthrax
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov