Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)

This is an interventional treatment trial for Congenital Adrenal Hyperplasia focused on measuring classic congenital adrenal hyperplasia (CAH), 21-hydroxylase deficiency Read More

Inclusion Criteria:

• Be willing and able to adhere to the study procedures, including all requirements at the study center, and return for the follow-up visit.
• Have a medically confirmed diagnosis of 21-hydroxylase deficiency CAH.
• Be on a stable regimen of steroidal treatment for CAH.
• Have elevated androgen levels.
• Patients of childbearing potential must be abstinent or agree to use appropriate birth control during the study.

Exclusion Criteria:

• Have a diagnosis of any of the other forms of classic CAH.
• Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.
• Have a clinically significant unstable medical condition or chronic disease other than CAH.
• Have a history of cancer unless considered to be cured.
• Have a known history of clinically significant arrhythmia or abnormalities on ECG.
• Have a known hypersensitivity to any corticotropin-releasing hormone antagonist.
• Have received an investigational drug within 30 days before initial screening or plan to use an investigational drug (other than the study drug) during the study.
• Have current substance dependence or substance (drug) or alcohol abuse.
• Have had a significant blood loss or donated blood or blood products within 8 weeks prior to the study.