Ignite Creation Date:
2024-05-06 @ 12:15 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03718234
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2018-10-11
Brief Title:
Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Interval Bolus Delivery of Subcutaneous Hydrocortisone Via Infusion Pump in Children With Congenital Adrenal Hyperplasia
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label non-randomized crossover design feasibility trial comparing oral hydrocortisone treatment with interval bolus delivery pulsatile of subcutaneous hydrocortisone via infusion pump in children with congenital adrenal hyperplasia Eight children ages 4-18 yrs will have 24-hr pharmacokinetic and pharmacodynamic profiles of cortisol 17-hydroxyprogesterone and androstenedione concentrations while on oral hydrocortisone therapy admission 1 during an initial trial of the subcutaneous hydrocortisone pump admission 2 and after 6 weeks of subcutaneous hydrocortisone pump treatment admission 3 An integrated pharmacokinetic and pharmacodynamic model will be used to determine cortisol 17-hydroxyprogesterone and androstenedione parameters to compare the duration of time subjects have these concentrations outside acceptable ranges Funding Source - FDA OOPD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-6100 | OTHER_GRANT | FDA Office of Orphan Products Development | None |