Status:
COMPLETED
Pharmacokinetics of Amiodarone in Children
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Heart Rhythm Disorder
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief Summary
PK-AMIO study is a population pharmacokinetic study of Amiodarone in children in order to : * study the pharmacokinetic parameters (Pop PK) of Amiodarone in children; * identify covariates explaining...
Detailed Description
The incidence of supraventricular rhythm disorders in children is 1/250 to 1/1000. Amiodarone is used until the age of 1 year to limit the risk of recurrence. Efficiency is around 60% with no predicti...
Eligibility Criteria
Inclusion
- All children from 0 to 18 years old treated with Amiodarone for any rhythm disorder, and followed to Necker-Enfants maladies hospital.
Exclusion
- Absence of parental and / or child consent
- Known liver dysfunction
Key Trial Info
Start Date :
February 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2020
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03842020
Start Date
February 13 2019
End Date
December 12 2020
Last Update
August 28 2025
Active Locations (1)
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1
Necker Hospital
Paris, France, 75015