A Phase 1 interventional study of Subcutaneous hydrocortisone in Congenital Adrenal Hyperplasia, Hyperplasia and Adrenal Hyperplasia, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by University of Minnesota · Phase 1, Interventional, and Treatment
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
101 studies on the registry are indexed under Adrenal Hyperplasia, Congenital; 28 are open to participants now.
This study's enrollment of 11 is below the median of 37 across 50 interventional studies indexed under Adrenal Hyperplasia, Congenital.
Browse Adrenal Hyperplasia, Congenital studies →University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
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Exclusion Criteria:
Patients on:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a single arm study. Upon enrollment each participant was admitted for a 24-hr PKPD profile of cortisol, 17OHP and A4 concentrations while on standard oral hydrocortisone therapy (admission 1, week 1). Participant continued on stable oral HC for six weeks. On admission 2, week 7, participant was admitted SQHC pump placement and a safety check was performed to verify absorption of HC was adequate. This consisted of an identical 24-hr PKPD design as used in admission 1. The participants returned to their standard oral HC dosing for 2 weeks while the PKPD profiles from the SQHC pump were being evaluated. The SQHC pump was placed at week 9 and then sent home on the pump. .After 6 weeks of SQHC pump treatment (admission 3, week 14) the participants were admitted and the same 24-hour PKPD design as admissions 1 and 2 profiles was conducted. The subjects were then discharged on their standard oral HC therapy and were followed for an additional 6 weeks
Drug: Subcutaneous hydrocortisone
Pulsatile subcutaneous hydrocortisone administered in 8 doses per day via SQ infusion pump for 6 weeks
Also known as: Hydrocortisone delivered via subcutaneous pump
Cortisol Exposure
24-hour area under the curve (AUC) following oral hydrocortisone dosing (admission 1).
Time frame: Week 1
Cortisol Exposure
The 24-hour cortisol area-under-the curve (AUC) while on the interval bolus delivery (pulsatile) of SQHC (admission 3)
Time frame: Week 14
17-OHP Exposure
24-hour area under the curve (AUC) following oral hydrocortisone dosing (admission 1).
Time frame: Week 1
17-OHP Exposure
The 24-hour cortisol area-under-the curve (AUC) while on the interval bolus delivery (pulsatile) of SQHC (admission 3)
Time frame: Week 14
Androstenedione (A4) Exposure
24-hour area under the curve (AUC) following oral hydrocortisone dosing (admission 1).
Time frame: Week 1
Androstenedione (A4) Exposure
The 24-hour cortisol area-under-the curve (AUC) while on the interval bolus delivery (pulsatile) of SQHC (admission 3)
Time frame: Week 14
| Milestone | Subcutaneous Hydrocortisone Via Infusion Pump |
|---|---|
| Started | 11 |
| Completed | 8 |
| Not completed | 3 |
24-hour area under the curve (AUC) following oral hydrocortisone dosing (admission 1).
| hr*mcg/dL | Subcutaneous Hydrocortisone Via Infusion Pump |
|---|---|
| Cortisol Exposure | 110 ± 9.96 |
The 24-hour cortisol area-under-the curve (AUC) while on the interval bolus delivery (pulsatile) of SQHC (admission 3)
| hr*mcg/dL | Subcutaneous Hydrocortisone Via Infusion Pump |
|---|---|
| Cortisol Exposure | 118 ± 9.10 |
24-hour area under the curve (AUC) following oral hydrocortisone dosing (admission 1).
| hr*ng/dL | Subcutaneous Hydrocortisone Via Infusion Pump |
|---|---|
| 17-OHP Exposure | 46700 ± 19200 |
The 24-hour cortisol area-under-the curve (AUC) while on the interval bolus delivery (pulsatile) of SQHC (admission 3)
| hr*ng/dL | Subcutaneous Hydrocortisone Via Infusion Pump |
|---|---|
| 17-OHP Exposure | 26900 ± 16200 |
24-hour area under the curve (AUC) following oral hydrocortisone dosing (admission 1).
| hr*ng/dL | Subcutaneous Hydrocortisone Via Infusion Pump |
|---|---|
| Androstenedione (A4) Exposure | 3350 ± 2410 |
The 24-hour cortisol area-under-the curve (AUC) while on the interval bolus delivery (pulsatile) of SQHC (admission 3)
| hr*ng/dL | Subcutaneous Hydrocortisone Via Infusion Pump |
|---|---|
| Androstenedione (A4) Exposure | 1420 ± 968 |
Collected over 20 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subcutaneous Hydrocortisone Via Infusion Pump | 0/11 (0%) | 0/11 (0%) | 9/11 (81.8%) |
| Standard Glucocorticoid Therapy | 0/11 (0%) | 0/11 (0%) | 9/11 (81.8%) |
| Event | Subcutaneous Hydrocortisone Via Infusion Pump | Standard Glucocorticoid Therapy |
|---|---|---|
| Stinging/Burning sensationGeneral disorders | 8/11 | 8/11 |
| ItchingGeneral disorders | 5/11 | 5/11 |
| ErythemaGeneral disorders | 4/11 | 4/11 |
| ExcoriationGeneral disorders | 2/11 | 2/11 |
| FeverGeneral disorders | 2/11 | 2/11 |
| Skin rashGeneral disorders | 1/11 | 1/11 |
| HivesGeneral disorders | 1/11 | 1/11 |
| FatigueGeneral disorders | 1/11 | 1/11 |
| HeadacheGeneral disorders | 1/11 | 1/11 |
| Nasal congestionGeneral disorders | 1/11 | 1/11 |
| Age, Categorical(Participants) | Subcutaneous Hydrocortisone Via Infusion Pump |
|---|---|
| <=18 years | 11 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Subcutaneous Hydrocortisone Via Infusion Pump |
|---|---|
| Female | 5 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | Subcutaneous Hydrocortisone Via Infusion Pump |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2019 to primary completion in Feb 2023, 49 months.
Results were first posted in Jun 2025, 2 years 4 months after primary completion.
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Studies of the drug tested here: Hydrocortisone
Adrenal Hyperplasia, Congenital →