Chronocort Versus Standard Hydrocortisone Replacement Therapy to Treat Congenital Adrenal Hyperplasia in Participants Aged 16 Years and Over

Overview

About this study

The purpose of this study is to compare the effectiveness, safety, and tolerability of Chronocort (study drug) with standard of care medication, Immediate-Release Hydrocortisone (IRHC-Cortef) on subjects and their condition (CAH) to find out which is better.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Male or female participants must be aged 16 years or older at the time of signing the
informed consent/assent.

- In participants aged <18 years, height velocity must be less than 2 cm/year in the
last year and puberty must be completed (Tanner stage V).

- Participants with known classic CAH due to 21 hydroxylase deficiency diagnosed in
childhood with documented (at any time) elevated 17-OHP and with or without elevated
A4 and currently treated with hydrocortisone, prednisone, prednisolone or
dexamethasone (or a combination of the aforementioned glucocorticoids) and on stable
glucocorticoid therapy for a minimum of 3 months.

- Participants who are receiving fludrocortisone must be on a documented stable dose for
a minimum of 3 months prior to enrollment and must have stable renin levels at
screening.

- Female participants of childbearing potential and all male participants must agree to
the use of an accepted method of contraception during the study.

- A female participant is eligible to participate if she is not pregnant, not
breastfeeding, and she is either not a woman of childbearing potential (WOCBP) or has
a negative pregnancy test at entry into the study. Note: females presenting with
oligomenorrhea or amenorrhea who are aged ≤55 years should be considered potentially
fertile and therefore should undergo pregnancy testing like all other female
participants.

- Capable of giving signed informed consent/assent which includes compliance with
requirements and restrictions listed in the informed consent form (ICF) and in this
protocol.

Exclusion Criteria:

- Clinical or biochemical evidence of hepatic or renal disease e.g. creatinine >2 times
the upper limit of normal (ULN) or elevated liver function tests (alanine
aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times the ULN).

- History of bilateral adrenalectomy.

- History of malignancy (other than basal cell carcinoma successfully treated >26 weeks
prior to entry into the study).

- Participants who have type 1 diabetes or receive regular insulin, have uncontrolled
diabetes, or have a screening HbA1c greater than 8%..

- Persistent signs of adrenal insufficiency or the participant does not tolerate
treatment at the end of the 4-week run-in period.

- Participants with any other significant medical or psychiatric conditions that in the
opinion of the Investigator would preclude participation in the study.

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

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

- Participants who are receiving <10 mg hydrocortisone dose at screening or the
hydrocortisone dose equivalent.

- Participants anticipating regular prophylactic use of additional steroids e.g. for
strenuous exercise.

- Participation in another clinical study of an investigational or licensed drug or
device within the 12 weeks prior to screening.

- Inclusion in any natural history or translational research study that would require
evaluation of androgen levels during the study period outside of this protocol's
assessments.

- Participants who have previously been exposed to Chronocort in any Diurnal study.

- Participants who routinely work night shifts and so do not sleep during the usual
night-time hours.

- Participants, who in the opinion of the Investigator, will be unable to comply with
the requirements of the protocol.

- Participants with a known hypersensitivity to any of the components of the Chronocort
capsules, the Cortef tablets, or the placebo capsules.

- Participants with congenital galactosemia, malabsorption of glucose and galactose, or
who are lactase deficient.

- Participants with a body weight of 45 kg or less.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/18/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Irina Bancos, M.D., M.S.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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