National Active Surveillance Network and Pharmacogenomics of Adverse Drug Reactions in Children

StatusRecruiting
PhaseNot specified
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv23
  2. Primary and study completion dates: Mar 2026 to Mar 2029v22
  3. Primary and study completion dates: Mar 2024 to Mar 2026v21
  4. Collaborators revised (14)v20
  5. Primary and study completion dates: Mar 2023 to Mar 2024v19
Show 17 earlier versionsHide 17 earlier versions
  1. Primary and study completion dates: Jul 2020 to Mar 2023v18
  2. Primary and study completion dates: Jul 2019 to Jul 2020v17
  3. Primary and study completion dates: Dec 2018 to Jul 2019
    • Site contact updated
    v16
  4. 2 versions Re-verified since Jul 16, 2015, no change to tracked fieldsv14-v15
  5. Study Status, Outcome Measuresv13
  6. Primary completion date: Dec 2018
    • Study completion date: Dec 2013 to Dec 2018
    v12
  7. Collaborators: 13 to 14v11
  8. Re-verified, no change to tracked fieldsv10
  9. Enrollment target: 5000 to 7000
    • Eligibility criteria expanded, about 7 words
    • Study description expanded, about 2 words
    v9
  10. 3 versions Re-verified since Dec 14, 2010, no change to tracked fieldsv6-v8
  11. Study completion date: Feb 2009 to Dec 2013
    • Study description shortened, about 22 words
    • Collaborators: 12 to 13
    v5
  12. Collaborators: 13 to 12v4
  13. 2 versions Re-verified since Mar 28, 2008, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • 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 the study is (1) to identify and collect samples from children and adults who take drugs and have adverse drug reactions AND children and adults who take drugs and do not experience any adverse drug effects; (2) to determine if genetic differences between the two groups contribute to causing the adverse drug reactions; and (3) to develop patient specific drug dosing guidelines to prevent future adverse drug reactions. We also wish to compare the use of prescription drugs, medical and hospital services and vital statistics between BC participants who experience adverse drug reactions and those who do not. Study hypothesis: Genetic differences may contribute to patients' response to drugs and may be responsible for adverse drug reactions.
Trial Details
NCT Number NCT00414115
Lead Sponsor University of British Columbia
Collaborators: Genome Canada, Genome British Columbia, Child and Family Research Institute, Western University, Canada, Provincial Health Services Authority British Columbia, Health Canada, Canada Gene Cure, Eli Lilly and Company, Pfizer, Merck Sharp & Dohme LLC, Canadian Society of Clinical Pharmacology, Canadian Institutes of Health Research (CIHR), Canada Foundation for Innovation, British Columbia Clinical Genomics Network
Conditions
(from sponsor)		 Adverse Drug Reaction (ADR)
Related terms Drug-Related Side Effects and Adverse Reactions
Enrollment 7,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov