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Pharmacokinetics of Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT) in Pediatric Patients With a Confirmed or Suspected Exposure to Botulinum Neurotoxin

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Trial Profile

Pharmacokinetics of Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT) in Pediatric Patients With a Confirmed or Suspected Exposure to Botulinum Neurotoxin

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 30 May 2024

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At a glance

  • Drugs Botulinum-antitoxin (Primary)
  • Indications Botulism
  • Focus Pharmacokinetics
  • Sponsors Emergent BioSolutions
  • Most Recent Events

    • 28 Nov 2022 The study protocol amended to change primary endpoint from calculation of area under the concentration-time curve (AUC 0-24h) to margin of PK equivalence for 90% survival. Maximum age of patient to be enroll changed from 16 years to 11 years. Adolescent population excluded from the study.
    • 15 Nov 2022 Planned number of patients changed from 7 to 10.
    • 15 Nov 2022 Status changed from active, no longer recruiting to recruiting.
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