Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia
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- STATUS
- Recruiting
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- days left to enroll
- 35
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- participants needed
- 8
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- sponsor
- University of Minnesota
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 Identifier | NCT03718234 |
| Sponsor | University of Minnesota |
| Last Modified on | 13 February 2022 |
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