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
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Condition or disease | Intervention/treatment | Phase |
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Botulism | Biological: One 5 mL of blood will be collected. | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
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 Toxin. |
Actual Study Start Date : | October 2014 |
Actual Primary Completion Date : | July 2017 |
Actual Study Completion Date : | July 2017 |

Arm | Intervention/treatment |
---|---|
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.
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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.
|
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051062
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) |
Additional Information:
Publications:
Responsible Party: | Cangene Corporation |
ClinicalTrials.gov Identifier: | NCT02051062 History of Changes |
Other Study ID Numbers: |
BT-011 |
First Posted: | January 31, 2014 Key Record Dates |
Last Update Posted: | January 26, 2018 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Cangene Corporation:
Pharmacokinetics BAT Pediatric |
Additional relevant MeSH terms:
Botulism Clostridium Infections Gram-Positive Bacterial Infections Bacterial Infections Neuromuscular Junction Diseases Neuromuscular Diseases Nervous System Diseases Neurotoxicity Syndromes |
Foodborne Diseases Poisoning Chemically-Induced Disorders Antitoxins Botulinum Antitoxin Immunologic Factors Physiological Effects of Drugs |