Clinical Trial: BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational [Patient Registry]

Official Title: Botulinum Antitoxin Patient Registry for the Evaluation of Safety and Clinical Outcomes of Pediatric and Adult Patients Following BAT Treatment for Confirmed or Suspected Exposure to Botulinum Toxin.

Brief Summary: The purpose of the Registry will be to evaluate patient safety following Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric patients with a confirmed or suspected exposure to botulinum toxin. This Registry is intended to serve as an active surveillance system to further assess the safety profile for BAT® and to quantify the occurrence of unexpected adverse events, given that the current safety database is considered too small to reliably identify unexpected risks.

Detailed Summary:

Objectives: The primary objective of the Registry is to estimate the absolute risk (incidence rates) of hypersensitivity /allergic reactions, including serum sickness, febrile reactions, hemodynamic instability, bradycardia, and other serious adverse events in pediatric and adult patients who are administered Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®).

The secondary objectives of the Registry are to:

  • Evaluate the safety of BAT® used to treat patients with a confirmed or suspected exposure to botulinum toxin.
  • Collect and summarize clinical outcome information in patients treated with BAT®.
  • Validate the design of a patient Registry to be implemented in the event of a mass botulinum toxin exposure scenario.

Subject Population: The base population will include all patients in the United States of America with a confirmed or suspected exposure to botulinum toxin who are treated with BAT®. There are no age or gender restrictions.

Sample Size: The study size goal is enrollment of a minimum of 100 patients into the Registry during a 3-year recruitment period, including at least 10 pediatric patients under the age of 17-years. Enrollment into the Registry will be closed once the minimum sample size has been achieved or after 3-years, whichever occurs last.

Registry Location: Any hospitals /facilities treating a patient with a confirmed or suspected exposure to botulinum toxin who was treated with BAT® from the Center for Disease Control and Prevention Strategic National Stockpile or State stockpiles are eligible for participa
Sponsor: Cangene Corporation

Current Primary Outcome: Number of participants with serious and non-serious adverse events [ Time Frame: From BAT® administration up to discharge from hospital (200 days) ]

The data obtained will more clearly define the absolute risk (incidence rates) of hypersensitivity / allergic reactions, including serum sickness, febrile reactions, hemodynamic instability, bradycardia, and other serious adverse events in pediatric and adult patients that are treated with BAT® due to a confirmed or suspected case of botulism.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cangene Corporation

Dates:
Date Received: January 29, 2014
Date Started: October 2014
Date Completion: December 2017
Last Updated: April 1, 2016
Last Verified: April 2016