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

Launched by NEUROCRINE UK LIMITED · Mar 18, 2022

Keywords

ClinConnect Summary

Participants in eligible countries completing one of the specified previous Chronocort studies (DIUR-006 and DIUR 014) can either continue Chronocort treatment (if the participant received Chronocort in the feeder study) or switch to Chronocort treatment (if the participant received standard glucocorticoid therapy in the feeder study) in this open-label extension study. All participants choosing to enter this extension study will have the study procedures fully explained and informed consent obtained, prior to, or at the last visit of the feeder study. Participants who agree to take part in...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants with Congenital Adrenal Hyperplasia (CAH) who have successfully completed Chronocort study DIUR-006 (sites in France and US only) or study DIUR-014.
• • Participants who are capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the study's informed consent form (ICF) and in the protocol.
• 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 (Note: this exclusion criterion is only applicable for French sites).