Trial record 2 of 3 for:    Open Studies | "Botulism"

Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Cangene Corporation
Sponsor:
Information provided by (Responsible Party):
Cangene Corporation
ClinicalTrials.gov Identifier:
NCT02051062
First received: January 29, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  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 Phase
Botulism
Procedure: One 5 mL of blood will be collected.
Phase 4

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.

Resource links provided by NLM:


Further study details as provided by Cangene Corporation:

Primary Outcome Measures:
  • 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: February 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blood sample obtained

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.

Procedure: One 5 mL of blood will be collected.
One 5 mL of blood will be collected.

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
Criteria

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 Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02051062

Contacts
Contact: Tim Babinchak, MD 484-318-8851 tbabinchak@cangene.com

Sponsors and Collaborators
Cangene Corporation
  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: January 29, 2014
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014