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BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients

StatusEnrolling by Invitation
PhasePhase 4
Started
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Record History

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  1. Primary and study completion dates: Jul 31, 2027 to Jul 31, 2028v14
  2. Re-verified, no change to tracked fieldsv13
  3. Study Identification, Study Status, Oversight, Eligibility, Contacts/Locationsv12
  4. Study Status, Contacts/Locationsv11
  5. 3 versions Re-verified since Jan 30, 2023, no change to tracked fieldsv8-v10
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Active, Not Recruiting to Enrolling by Invitationv7 Show 8 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 7 to 10
    • Interventions: A minimum of one 5 mL serum sample (up to three per enrolled subject) will be collected. (Biological) to Blood sample collection (Biological)
    • Secondary endpoints revised (8)
    • Study description shortened, about 98 words
    • Collaborators shortened, about 6 words
    • Publications: 6 to 4
    • Eligibility criteria shortened, about 4 words
  2. Lead sponsor: Cangene Corporation to Emergent BioSolutionsv6 Show 10 more changesShow less
    • Enrollment target: 3 to 7
    • Primary and study completion dates: Jul 2017 to Jul 31, 2027
    • Primary endpoint revised
    • Trial status: Completed to Active, Not Recruiting
    • Interventions: One 5 mL of blood will be collected. (Biological) to A minimum of one 5 mL serum sample (up to three per enrolled subject) will be collected. (Biological)
    • Secondary endpoints expanded, about 94 words
    • Study description shortened, about 38 words
    • Collaborators expanded, about 6 words
    • Publications: 4 to 6
    • Eligibility criteria expanded, about 4 words
  3. Trial status: Enrolling by Invitation to Completed
    • Enrollment target: estimated 10 to confirmed 3
    • Primary completion date changed from estimate of Oct 2017 to Jul 2017
    • Study completion date changed from estimate of Apr 2018 to Jul 2017
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Phase: Not applicable to Phase 4v3 Show 4 more changesShow less
    • Interventions: One 5 mL of blood will be collected. (Procedure) to One 5 mL of blood will be collected. (Biological)
    • Eligibility criteria expanded, about 14 words
    • Study description expanded, about 7 words
    • Study title expanded, about 1 word
  6. Phase: Phase 4 to Not applicablev2 Show 6 more changesShow less
    • Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Primary completion date: Jan 2017 to Oct 2017
    • Start date: Feb 2014 to Oct 2014
    • Study completion date: Jun 2017 to Apr 2018
    • Eligibility criteria revised
    • Study description revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to verify the pediatric dosing recommendations for BAT product in pediatric patients that are treated with BAT product due to a confirmed or suspected case of botulism. A minimum of one serum sample should be collected but whenever feasible additional serum samples (up to three per enrolled participant) may be collected from the participant or obtained from surplus standard of care samples, if available, within 32 hours after BAT product administration. Safety of the BAT product will also be evaluated. Emergent will follow-up with the physician by telephone after 30 days post-BAT product administration to collect AEs, SAEs, and unanticipated events.
Trial Details
NCT Number NCT02051062
Lead Sponsor Emergent BioSolutions
Conditions
(from sponsor)		 Botulism
Related terms Botulism
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov