At a glance
ClinicalIndex Comparison RecordN/ACompleted· 146 enrolled
Drug / intervention
Pharmacokineticbiological
Likely dose
Pharmacokinetic 2 mlfrom record
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Study of Pharmacokinetic Variability of Glucocorticoids in Children
In Brief
An observational study evaluating Pharmacokinetic for Children Receiving Prednisone or Prednisolone or Methylprednisolone or Hydrocortisone. Completed, enrolled 146 participants across 1 site.
Detailed Summary
The purpose of this study is to determine individual susceptibility factors (drug interactions, genetic factors such as enzyme polymorphism…) to explain wide interindividual variability towards corticosteroids (prednisone, prednisolone, methylprednisolone, hydrocortisone) in children, which could establish a base for therapeutic monitoring.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
CollaboratorsURC-CIC Paris Descartes Necker Cochin
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartDec 2014
Primary CompletionDec 2021
TodayJul 2026
First PostedSep 30, 2014
Enrollment StartDec 3, 2014
Primary CompletionDec 9, 2021
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 11.8 years ago
Interventions
Pharmacokineticbiological
Blood sample of 2 ml at enrolment and then at following visits. Buccal cell collection swab