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: 29 Jan 2026

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At a glance

16 Jan 2026 Planned End Date changed from 31 Jul 2027 to 31 Jul 2028.
16 Jan 2026 Planned primary completion date changed from 31 Jul 2027 to 31 Jul 2028.
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.

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