Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Botulism |
Procedure: One 5 mL of blood will be collected. |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: 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. |
- Area Under the Concentration-Time Curve (AUC 0-24h) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 10 |
| Study Start Date: | October 2014 |
| Estimated Study Completion Date: | April 2018 |
| Estimated Primary Completion Date: | October 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: One 5 mL blood sample 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.
|
Procedure: 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.
|
Detailed Description:
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) 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 serum concentration(s) obtained will be modeled using a population pharmacokinetic approach based on a previously developed model for BAT serotypes A-G in healthy adult human subjects.
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.
Eligibility| Ages Eligible for Study: | up to 16 Years |
| Genders Eligible for Study: | Both |
| 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:
- Blood sample cannot be collected prior to 24 hours post-BAT® administration.
- The 5 mL blood sample volume is deemed to be unsafe based on patient weight.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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) |
More Information
Additional Information:
Publications:
| Responsible Party: | Cangene Corporation |
| ClinicalTrials.gov Identifier: | NCT02051062 History of Changes |
| Other Study ID Numbers: | BT-011 |
| Study First Received: | January 29, 2014 |
| Last Updated: | December 23, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cangene Corporation:
|
Pharmacokinetics BAT Pediatric |
Additional relevant MeSH terms:
|
Botulism Bacterial Infections Chemically-Induced Disorders Clostridium Infections Foodborne Diseases Gram-Positive Bacterial Infections Nervous System Diseases Neuromuscular Diseases |
Neuromuscular Junction Diseases Neurotoxicity Syndromes Poisoning Botulinum Antitoxin Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 25, 2015