Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03569514
Study type Observational
Source Emergent BioSolutions
Contact Gideon Akintunde, MD
Phone 204 275 4060
Email AkintundG@ebsi.com
Status Not yet recruiting
Phase
Start date February 11, 2025
Completion date July 2026

See also
  Status Clinical Trial Phase
Completed NCT00114621 - Anthrax Vaccine Clinical Trials Phase 1
Recruiting NCT00050310 - Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients
Completed NCT01453907 - Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers Phase 1
Completed NCT01491607 - Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults Phase 3
Completed NCT03518125 - BARDA Securing Anthrax Immunity For the Elderly Phase 2
Completed NCT04660201 - Anthrax AV7909 Liquid vs Lyophilized Phase 1
Completed NCT04320485 - Evaluation of the Clinical Specificity of the Active Anthrax Detectâ„¢ Plus (AAD Plus) Lateral Flow Immunoassay (LFI)
Recruiting NCT06365073 - A Case-control Study on the Clinical Characteristics of 28-day and 90-day Death From Severe Anthrax
Completed NCT03877926 - VELOCITY: An Anthrax Vaccine Clinical Study Phase 3
Completed NCT03498027 - Febrile Whole Blood Specimen Collection and Testing
Terminated NCT00964834 - Ph1 Study of Valortim and Doxycycline in Humans Phase 1
Completed NCT00063843 - Anthrax-rPA: Safety, Tolerability, Immunogenicity Phase 1
Completed NCT01624532 - A Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 Phase 2
Completed NCT04148118 - A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Anthrax Vaccine in Healthy Adults Phase 1
Terminated NCT05672875 - Evaluation of the SRI B. Anthracis Lethal Factor Diagnostic System
Completed NCT01770743 - A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels Phase 2
Completed NCT01867957 - Efficacy and Safety of Anthrax Vaccine, GC1109 Phase 1
Completed NCT00845650 - Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV) Phase 1/Phase 2
Completed NCT00031291 - Plasmapheresis of Anthrax-Vaccinated Subjects for Production of Anthrax Immune Globulin N/A
Recruiting NCT05997264 - Anthrax AV7909 Boost Evaluation Study Phase 2