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Corticosteroid
Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia
Phase 1
Waitlist Available
Led By Kyriaki Sarafoglou, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization assessed up to 20 weeks.
Awards & highlights
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group
Summary
This trial is testing two methods of giving hydrocortisone to children aged 4-18 with congenital adrenal hyperplasia. One method uses pills, and the other uses a small pump under the skin. The goal is to find out which method better controls their hormone levels. Hydrocortisone is the standard treatment for children with congenital adrenal hyperplasia (CAH).
Eligible Conditions
- Congenital Adrenal Hyperplasia
- Adrenal Hyperfunction
- Skin Hyperplasia
- Intersex
- Genetic Diseases
- Adrenal Hyperplasia
- Genitourinary Disorder
- Cushing's Syndrome
- Hydrocortisone
- Hyperplasia
- Congenital Disorders
- Intersex Conditions
- Urogenital Abnormalities
- Genetic Disorders
- Adrenal Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization assessed up to 20 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization assessed up to 20 weeks.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Duration of hypocortisolemia and hypercortisolemia will be significantly shorter
Serum concentrations will be within an acceptable range
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Subcutaneous Hydrocortisone via Infusion PumpExperimental Treatment1 Intervention
Patients will receive a subcutaneous injection of hydrocortisone (HC). Each patient's total daily dose (TDD) of oral tablet hydrocortisone to determine the doses to be delivered of the study drug. The 24-hr schedule and percentage of the TDD of HC will be as follows: approximately 60% of the TDD of HC will be delivered in 3 equal pulses at 0300, 0600 and 0900. Another 35% will be delivered in 3 equal pulses at 1200, 1500 and 1800 and the remaining 5% at 2100 and 2400.
Group II: Standard glucocorticoid therapyActive Control1 Intervention
Subjects in this arm will continue on standard oral hydrocortisone therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocortisone
FDA approved
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,621,947 Total Patients Enrolled
Kyriaki Sarafoglou, MDPrincipal InvestigatorUniversity of Minnesota