A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Subjects completing study DIUR-005 and those who have already completed study DIUR-003 will be offered the opportunity either to continue Chronocort® therapy or to switch from their current glucocorticoid therapy to Chronocort® in this open-label study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Diurnal Limited
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

Inclusion Criteria:

1. Subjects with CAH who have successfully completed a clinical trial with the current formulation of Chronocort®.

2. Provision of signed written informed consent.

Exclusion Criteria:

1. Co-morbid condition requiring daily administration of a medication (or use of any medications/supplements) 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 ULN]).

3. Females who are pregnant or lactating.

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

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

6. Subjects with a history of bilateral adrenalectomy.

7. Participation in another clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study, except for another clinical trial with the current formulation of Chronocort®.

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

9. Subjects who routinely work night shifts and so do not sleep during the usual nighttime hours.