Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
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
Phase:
Phase 1
Details
Lead Sponsor:
University of Minnesota University of Minnesota - Clinical and Translational Science Institute