Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase III study is an open-label extension study to be conducted at approximately 36 investigational sites across 3 countries. The study will evaluate the long-term safety and tolerability of Chronocort in participants aged 16 years and over when used as treatment for Congenital Adrenal Hyperplasia (CAH).

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

Details

• Lead Sponsor: Diurnal Limited
• Treatments: Hydrocortisone

Criteria

Inclusion Criteria:

• Participants with Congenital adrenal hyperplasia (CAH), in eligible countries who have successfully completed one of the specified previous Chronocort studies (DIUR-006 or DIUR-014).

• Participants who are capable of giving signed informed consent/assent.

Exclusion Criteria:

• Participants with 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).

• Participants with a history of malignancy (other than basal cell carcinoma successfully treated >26 weeks prior to entry into the study).

• Participants with a history of bilateral adrenalectomy.

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

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

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

• 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 3 months prior to inclusion in this study, except for another clinical study with the current formulation of Chronocort.

• Females who are pregnant or lactating.

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

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

• Participants with a body weight of 50 kg or less.