Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    8
  • sponsor
    University of Minnesota
Updated on 13 February 2022
epinephrine
oral hydrocortisone
17-hydroxyprogesterone
classic congenital adrenal hyperplasia
androstenedione
glucocorticoid therapy

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

Details
Condition Congenital Adrenal Hyperplasia, Hyperplasia, Adrenal Hyperplasia, Congenital Disorders, Adrenocortical Hyperfunction, Disorders of Sex Development, Urogenital Abnormalities, Genetic Diseases, Inborn, Steroid Metabolic Diseases, Inborn, Adrenal Gland Disease, Hydrocortisone
Treatment standard glucocorticoid therapy, Subcutaneous hydrocortisone
Clinical Study IdentifierNCT03718234
SponsorUniversity of Minnesota
Last Modified on13 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Children 4 - 18 years of age
Classic congenital adrenal hyperplasia (CAH) as confirmed by hormonal and molecular testing
Patients who have been on the same HC dosing regimen for 1 month

Exclusion Criteria

Patients with non-classic CAH
Patients on
Dexamethasone
Prednisone, or
inhaled steroids
Patients with body surface areas under 1m2 or over 2m2
Non-English speaking patients
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