Clinical Trial: BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: 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
Brief Summary: The purpose of this study is to verify the pediatric dosing recommendations for BAT® in pediatric patients that are treated with BAT® due to a confirmed or suspected case of botulism. One 5 mL blood sample will be obtained within 24 hours post BAT® administration. Study BT-011 will be run concurrently with the BAT patient registry (BT-010).
Detailed Summary:
Objectives: The purpose of this study is to collect one serum sample from pediatric patients in order to analyze the pharmacokinetics of BAT® to verify the currently approved pediatric dosing recommendations.
Protocol Design: This is a single arm, multi-site Pharmacokinetics study in pediatric patients treated with BAT®. The study begins once participation in the study is confirmed by the physician and informed consent/assent is obtained from the patient and/or guardian. Concurrent participation in the BAT patient registry (BT-010) by the treating physician/facility is encouraged to collect safety and clinical outcome data.
Assessments: One 5 mL of blood collected to yield 2 mL serum sample will be collected post-BAT® administration. The blood sample should be collected no later than 24 hours post BAT® administration. To ensure sufficient detectable circulating levels of BAT® for pharmacokinetic analysis the target window of time for collection should be between 6 and 24 hours post-BAT® administration.
Pharmacokinetic or Efficacy Parameters: The BAT® serum concentration(s) obtained will be modeled using a population pharmacokinetic approach based on a previously developed model for BAT® in healthy adult human subjects for toxin serotypes A-G.
Individual Bayesian Pharmacokinetics parameters (i.e. clearance (CL), volume of distribution (Vc), volume of distribution of the central and the peripheral compartments (Vp)) and corresponding exposure metrics will be derived from the population analysis.
Primary Endpoints: The primary endpoint is the dosage level at which pharmacokinetic equivalence is reached i.e. the dosage at which BAT® is
Sponsor: Cangene Corporation
Current Primary Outcome: Area Under the Concentration-Time Curve (AUC 0-24h) [ Time Frame: 24 hours ]
One 5 mL of blood collected to yield 2 mL serum sample will be collected post-BAT® administration.
The blood sample should be collected no later than 24 hours post BAT® administration. To ensure sufficient detectable circulating levels of BAT® for Pharmacokinetic analysis the target window of time for collection should be between 6 and 24 hours post-BAT® administration.
The BAT® serum concentration(s) obtained will be modeled using a population pharmacokinetic approach based on a previously developed model for BAT® in healthy adult human subjects for toxin serotypes A-G.
Original Primary Outcome: Area Under the Concentration-Time Curve (AUC 0-24h) [ Time Frame: 24 hours ]
One 5 mL of blood collected to yield 2 mL serum sample will be collected post-BAT® administration.
The blood sample should be collected no later than 24 hours post BAT® administration. To ensure sufficient detectable circulating levels of BAT® for Pharmacokinetic analysis the target window of time for collection should be between 6 and 24 hours post-BAT® administration.
The serum concentration(s) obtained will be modeled using a population Pharmacokinetics approach based on a previously developed model for BAT™ serotypes A-G in healthy adult human subjects.
Individual Bayesian Pharmacokinetic parameters (i.e. clearance (CL), volume of distribution (Vc) , volume of distribution of the central and the peripheral compartments (Vp)) and corresponding exposure metrics will be derived from the population analysis.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Cangene Corporation
Dates:
Date Received: January 29, 2014
Date Started: October 2014
Date Completion: April 2018
Last Updated: August 19, 2016
Last Verified: August 2016
