Clinical Trials Directory

Trials / Completed

CompletedNCT03718234

Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia

Interval Bolus Delivery of Subcutaneous Hydrocortisone Via Infusion Pump in Children With Congenital Adrenal Hyperplasia

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
11 (actual)
Sponsor
University of Minnesota · Academic / Other
Sex
All
Age
4 Years – 18 Years
Healthy volunteers
Not accepted

Summary

This is an open-label, non-randomized, single arm proof-of concept feasibility trial comparing standard oral hydrocortisone (HC) treatment with a six-week intervention of interval bolus delivery (pulsatile) of subcutaneous (SQ) HC via infusion pump in children with congenital adrenal hyperplasia (CAH). Eight children, ages 4-18 yrs, will have 24-hr pharmacokinetic and pharmacodynamic (PKPD) profiles of cortisol, 17- hydroxyprogesterone (17OHP) and androstenedione (A4) concentrations while on standard oral hydrocortisone therapy (admission 1, week 1); during a safety check using a subcutaneous hydrocortisone pump (admission 2, week 7); and after 6 weeks of SQHC pump treatment (admission 3, week 14). A pharmacokinetic and pharmacodynamic analysis will be used to compare cortisol, 17OHP and A4 exposures between standard oral HC therapy (week 1) with SQHC pump treatment (week 14). Funding Source - FDA OOPD

Conditions

Interventions

TypeNameDescription
DRUGSubcutaneous hydrocortisonePulsatile subcutaneous hydrocortisone administered in 8 doses per day via SQ infusion pump for 6 weeks

Timeline

Start date
2019-01-01
Primary completion
2023-02-23
Completion
2023-02-23
First posted
2018-10-24
Last updated
2025-06-25
Results posted
2025-06-25

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03718234. Inclusion in this directory is not an endorsement.