Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02716818
• Date of registration: 26/02/2016
• Prospective Registration: No
• Primary sponsor: Diurnal Limited
• Public title: Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia
• Scientific title: A Phase III Study of Efficacy, Safety and Tolerability of Chronocort® Compared With Standard Glucocorticoid Replacement Therapy in the Treatment of Congenital Adrenal Hyperplasia
• Date of first enrolment: February 22, 2016
• Target sample size: 122
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02716818
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Debbie Merke, MD
• Affiliation: National Institutes of Health (NIH)

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Known CAH due to 21-hydroxylase deficiency (classic CAH) diagnosed in childhood with
documented (at any time) elevated 17-OHP and/or A4 and currently treated with
hydrocortisone, prednisone, prednisolone or dexamethasone (or a combination of the
aforementioned glucocorticoids) on a stable glucocorticoid therapy for a minimum of 6
months.

2. Provision of signed written informed consent.

3. Non-pregnant, non-lactating females who are post menopausal, naturally or surgically
sterile, or of childbearing potential with a negative urinary pregnancy test and using
a medically acceptable method of contraception.

4. Plasma renin activity (PRA) less than 1.5 times the upper limit of normal (ULN) at
screening or within 3 months prior to screening, except in subjects who have been
diagnosed with hypertension where the renin is not being used to monitor
fludrocortisone replacement.

5. Plasma renin activity (PRA) less than 1.5 times the upper limit of normal (ULN) at
screening or within 3 months prior to screening, except in subjects who have been
diagnosed with hypertension where the renin is not being used to monitor
fludrocortisone replacement.

Exclusion Criteria:

1. Co-morbid condition requiring daily administration of a medication (or consumption of
any material) that interferes with the metabolism of glucocorticoids.

2. Clinical or biochemical evidence of hepatic or renal disease. Creatinine over twice
the ULN or elevated liver function tests (ALT or AST >2 times the ULN).

3. Subjects on regular daily inhaled, topical, nasal or oral steroids for any indication
other than CAH.

4. Subjects with any other significant medical or psychiatric conditions that in the
opinion of the investigator would preclude participation in the trial.

5. History of malignancy (other than basal cell carcinoma successfully treated >6 months
prior to entry into the study).

6. Participation in another clinical trial of an investigational or licensed drug or
device within the 3 months prior to inclusion in this study.

7. Subjects with a history of bilateral adrenalectomy.

8. Subjects having previously been exposed to Chronocort®.

9. Subjects unable to comply with the requirements of the protocol.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Congenital Adrenal Hyperplasia

Intervention(s)

Drug: Chronocort®

Drug: standard glucocorticoid therapy

Primary Outcome(s)

Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for 17-OHP [Time Frame: 24 weeks]

Secondary Outcome(s)

Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Fat Mass and Lean Mass) [Time Frame: Baseline and 24 weeks]

17-OHP and A4 by Individual Baseline Treatment Strata. [Time Frame: 24 weeks]

Number of Participants With 17-OHP and A4 Levels in the Optimal Range at 9:00 at Week 24 Visit [Time Frame: 24 weeks]

Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for A4 [Time Frame: 24 weeks]

Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Bone Mineral Density) - Measured at All Sites Except Germany. [Time Frame: Baseline and 24 weeks]

Secondary ID(s)

DIUR-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/09/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02716818