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

NCT00414115

Last updated date
Study Location
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3V4, Canada
Contact
604-875-2179

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Adverse Drug Reaction (ADR)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Children under 19 years who have taken drugs.

- Biological parents of children who have had an ADR.

- Patients/parents who speak and understand English (except in Quebec).

- Adults (for validation of findings in children)

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Adverse Drug Reaction (ADR)National Active Surveillance Network and Pharmacogenomics of Adverse Drug Reactions in Children
NCT00414115
  1. Vancouver, British Columbia
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title National Active Surveillance Network and Pharmacogenomics of Adverse Drug Reactions in Children
Official Title Canadian Pharmacogenomics Network for Drug Safety
Brief Summary

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.

Detailed Description

CPNDS will identify ADR predictive markers by comparing DNA and plasma samples from patients that suffer ADRs with samples from control populations that are stratified by medication type and age. The GATC will obtain its clinical material for ADR patients mainly, from hospital-based active surveillance network across Canada's major hospitals.

1. CPNDS will examine known SNPs in candidate genes related to the ADR (i.e. drug metabolism genes, drug transporter genes, drug target genes, and other disease-specific genes or genes related to the physiological pathway of the ADR.) 2. CPNDS will discover novel ADR predictive SNPs and mutations by sequencing DNA samples from our patient cohorts. CPNDS will also genotype and sequence DNA samples from populations of controls that received the same drugs, but did not suffer ADRs; and a second population of control patients who represent a random sample of the population of known ethnic backgrounds.

Novel ADR predictive SNPs and mutations will be functionally validated by pharmacokinetic approaches applied to time course analysis of drug concentrations for each specific genotype. Pharmacokinetic studies will also be used to determine the drug concentration in patients to characterize possible mechanisms of the ADR, translating into rational approaches to the choice of candidate genes to be examined in the genomic analyses.

The cost-effectiveness of an ADR screening program for the prevention of ADRs in children and adults will be calculated in detailed health-economic studies.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Children under 19 years who have taken drugs and adults to replicate findings in children
Condition Adverse Drug Reaction (ADR)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Carleton B, Poole R, Smith M, Leeder J, Ghannadan R, Ross C, Phillips M, Hayden M. Adverse drug reaction active surveillance: developing a national network in Canada's children's hospitals. Pharmacoepidemiol Drug Saf. 2009 Aug;18(8):713-21. doi: 10.1002/pds.1772.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 9, 2012)
7000
Original Enrollment
 (submitted: December 20, 2006)
5000
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Children under 19 years who have taken drugs.
  • Biological parents of children who have had an ADR.
  • Patients/parents who speak and understand English (except in Quebec).
  • Adults (for validation of findings in children)
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Bruce Carleton, PharmD.604-875-2179[email protected]
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00414115
Other Study ID Numbers H04-70358
CW Health Centre of BC
W04-0138
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bruce Carleton, University of British Columbia
Study Sponsor University of British Columbia
Collaborators
  • Genome Canada
  • Genome British Columbia
  • Child and Family Research Institute
  • University of Western Ontario, Canada
  • Provincial Health Services Authority
  • Health Canada
  • Canada Gene Cure
  • Eli Lilly and Company
  • Pfizer
  • Merck Sharp & Dohme Corp.
  • Canadian Society of Clinical Pharmacology
  • Canadian Institutes of Health Research (CIHR)
  • Canada Foundation for Innovation
  • British Columbia Clinical Genomics Network
Investigators
Principal Investigator:Bruce Carleton, Pharm. D.University of British Columbia
Principal Investigator:Michael Hayden, MD, Ph.DUniversity of British Columbia
PRS Account University of British Columbia
Verification Date April 2019