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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 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 11 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03718234
The ClinicalTrials.gov registry entry for NCT03718234 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Subcutaneous hydrocortisone is the first listed.
NCT03718234 reports 0 study locations.
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.
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