Status:
ENROLLING_BY_INVITATION
Long-term Safety Study of Chronocort in the Treatment of Participants with Congenital Adrenal Hyperplasia
Lead Sponsor:
Neurocrine UK Limited
Conditions:
Congenital Adrenal Hyperplasia
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
This phase III study is an open-label extension study to be conducted at approximately 21 investigational sites across 3 countries. The study will evaluate the long-term safety and tolerability of Chr...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT05299554
Start Date
April 1 2022
End Date
December 31 2025
Last Update
November 12 2024
Active Locations (21)
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1
Diurnal Investigational Site in California
Los Angeles, California, United States, 90027
2
Diurnal Investigational Site in California
Orange, California, United States, 92868
3
Diurnal Investigational Site in Florida
Jacksonville, Florida, United States, 32207
4
Diurnal Investigational Site in Iowa
Iowa City, Iowa, United States, 52242