An Open-label Extension Study to Evaluate the Long-term Safety andTolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over with Congenital Adrenal Hyperplasia

Phase 1

• Conditions: Congenital Adrenal Hyperplasia due to 21-hydroxylase deficiency; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2021-004467-26-FR
• Lead Sponsor: Diurnal Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-09
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

1. Participants with CAH who have successfully completed Chronocort study DIUR-006 (sites in France and US only) or study DIUR-014.
2. Participants who are capable of giving signed informed consent/assent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 141
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Medical Conditions
1. 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).
2. Participants with a history of malignancy (other than basal cell carcinoma successfully treated >26 weeks prior to entry into the study).
3. Participants with a history of bilateral adrenalectomy.
4. Participants with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the study.

Prior/Concomitant Therapy
5. Participants with a co-morbid condition requiring daily administration of a medication or consumption of any material that interferes with the metabolism of glucocorticoids (examples at http://medicine.iupui.edu/clinpharm/ddis/clinical-table/).
6. Participants on regular daily inhaled, topical, nasal, or oral steroids for any indication other than CAH.
7. Participants anticipating regular prophylactic use of additional steroids e.g., for strenuous exercise.
Prior/Concurrent Clinical Study Experience
8. 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.
Other Exclusions
9. Females who are pregnant or lactating.
10. Participants, who in the opinion of the Investigator, will be unable to comply with the requirements of the protocol.
11. Participants who routinely work night shifts and so do not sleep during the usual night-time hours.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified