Pharmacokinetics of Glucocorticoids in Children (GLUCOPED) | NCT02252237

Studies
Pharmacokinetics of Glucocorticoids in Children (GLUCOPED)

NCT02252237

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Nov 20, 2025Actual

Enrollment

146Actual

Phase

Not provided

Conditions

Children Receiving Prednisone or Prednisolone or Methylprednisolone or Hydrocortisone

Interventions

Pharmacokinetic

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 3, 2014Actual

Primary Completion Date

Dec 9, 2021Actual

Completion Date

Dec 9, 2021Actual

First Submitted Date

Sep 26, 2014

First Submission Date that Met QC Criteria

Sep 29, 2014

First Posted Date

Sep 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2025

Last Update Posted Date

Nov 20, 2025Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Corticosteroids are widely used in children. A large interindividual variability exists concerning both efficacity and tolerance. Pharmacokinetic is poorly known.

A knowledge of individual susceptibility factors would allow to better adapt therapy in each case.

Drugs evaluated here are used in routine care in children and will be prescribed according to department practices concerning treated disease. Medical checks will be done during usual follow-up. Several features will be collected: reason of treatment, drug chosen and prescription modalities, observance, concomitant treatments, side effects, clinical examination, photography, score… Blood samples will be performed at different interval during usual biological follow-up. Three samples per patient will be required for pharmacokinetic and pharmacogenetic.

170 children under prednisone/prednisolone,130 under methylprednisolone, and 100 children under hydrocortisone will be recruited in four pediatric medical departments: immuno-hematology, nephrology,dermatology, and pediatric neurology.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

146Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children with glucocorticoids		Children receiving Prednisone or Prednisolone or Methylprednisolone Pharmacokinetic	Biological: Pharmacokinetic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pharmacokinetic	Biological	Blood sample of 2 ml at enrolment and then at following visits. Buccal cell collection swab	Children with glucocorticoids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite of Pharmacokinetic parameter for Prednisone, Prednisolone, Methylprednisolone, hydrocortisone	Assessed by: Volume of distribution of creatinine Creatinine clearance	24 months

Secondary Outcomes

Measure	Description	Time Frame
Side effects	Ferryman and Gallwey score	24 months
Side effects	Dermaphot® score	24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

receiving Prednisone or Prednisolone or Methylprednisolone or hydrocortisone
recruited in Immuno-hematological unit, dermatological unit, in pediatric nephrological unit, pediatric intensive care unit, or pediatric neurology unit
parental agreement

Exclusion Criteria:

parental refusal
inability to take a blood sample
inhaled corticoids intake in the 3 previous days
topical corticoids intake in the 3 previous days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Children receiving glucocorticoids (Prednisone or Prednisolone or Methylprednisolone or hydrocortisone) are recruited in Immuno-hematological unit, dermatological unit, in pediatric nephrological unit, pediatric intensive care unit, or pediatric neurology unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Marc Tréluyer, MD-PhD	Assistance Publique - Hôpitaux de Paris	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AP-HP Necker		Paris		75015	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15059065	Background	Jamroziak K, Mlynarski W, Balcerczak E, Mistygacz M, Trelinska J, Mirowski M, Bodalski J, Robak T. Functional C3435T polymorphism of MDR1 gene: an impact on genetic susceptibility and clinical outcome of childhood acute lymphoblastic leukemia. Eur J Haematol. 2004 May;72(5):314-21. doi: 10.1111/j.1600-0609.2004.00228.x.
6721988

ID	Term
D011110	Polymorphism, Genetic
D014644	Genetic Variation
D055614	Genetic Phenomena