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NCT03718234 · ClinicalTrials.gov registry record · Phase 1
Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03718234: Completed Phase 1 study, sponsored by University of Minnesota.
NCT03718234 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03718234, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study 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
Primary Outcome
24-hour area under the curve (AUC) following oral hydrocortisone dosing (admission 1).
Interventions
- DRUG Subcutaneous hydrocortisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-01-01 |
| Est. Completion | 2023-02-23 |
| Phase | Phase 1 |
What the finished NCT03718234 record still lists
NCT03718234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Subcutaneous hydrocortisone is the first listed.
NCT03718234 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03718234 about?
NCT03718234 is a clinical study titled "Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia". 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 (CA...
What is the current status of trial NCT03718234?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2019-01-01. Estimated completion is 2023-02-23.
What interventions are being tested in trial NCT03718234?
The interventions under investigation include: Subcutaneous hydrocortisone (DRUG).
Who is sponsoring clinical trial NCT03718234?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03718234's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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