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BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT02051062
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Cangene Corporation

January 29, 2014
January 31, 2014
January 26, 2018
October 2014
July 2017   (Final data collection date for primary outcome measure)
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.

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.

Complete list of historical versions of study NCT02051062 on ClinicalTrials.gov Archive Site
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BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients
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 Toxin.
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).

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 most effective against the symptoms of botulism. Following the estimation of exposure in pediatric patients, and similar to what was done for adult subjects, the margin of efficacy for 90% survival will be estimated in order to verify the appropriateness of the administered pediatric dose.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Botulism
Biological: One 5 mL of blood will be collected.
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.
Experimental: One 5 mL blood sample will be collected
A single 5 mL blood sample will be collected from pediatric patients treated with BAT®. 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.
Intervention: Biological: One 5 mL of blood will be collected.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
10
July 2017
July 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Informed consent/assent (as applicable) is required for provision of a serum sample to Cangene.
  • Pediatric patients [age category: pediatric—preterm and term newborn infants (0 to 27 days), infants and toddlers (28 days to 23 months), children (2 to 11-years), and adolescents (12 to 16-years)]
  • Confirmed or suspected exposure to botulinum toxin.
  • Treatment with BAT® deployed from the Strategic National Stockpile or state stockpiles.

Exclusion Criteria:

  • If a blood sample cannot be collected from the pediatric subject within 24 hours of BAT® administration then the subject is excluded from the study.
  • The 5 mL blood sample volume is deemed to be unsafe based on patient weight.
Sexes Eligible for Study: All
up to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02051062
BT-011
No
Not Provided
Plan to Share IPD: No
Cangene Corporation
Cangene Corporation
Not Provided
Study Chair: Jason S Richardson, PhD Clinical Research Scientist for Cangene Corporation (doing business as Emergent Biosolutions)
Study Chair: Matt Cromie, MSc Clinical Research Senior Manager for Cangene Corporation (doing business as Emergent Biosolutions)
Study Chair: Christine Hall, PhD Director Clinical Research for Cangene Corporation (doing business as Emergent Biosolutions)
Cangene Corporation
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP