Subcutaneous hydrocortisone for 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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization assessed up to 20 weeks. for reporting.

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

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