A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

eurocrine Biosciences, Inc.0 个研究点目标入组 81 人开始时间: 2021年5月10日最近更新: 2024年6月10日

适应症

试验速览

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•- Be willing and able to adhere to the study procedures, including all requirements at the study center and return for the follow-up visit.
•- Be a female or male 2 to 17 years of age with a body weight of at least 10 kg.
•- Have a medically confirmed diagnosis of classic CAH due to 21- hydroxylase deficiency.
•- Be on a stable regimen of glucocorticoid treatment for CAH.
•- Have elevated adrenal androgens.
•- If treated with fludrocortisone, dose should be stable for at least 1 month prior to screening. Regardless of fludrocortisone treatment, upright plasma renin activity (PRA) (in the absence of medications that confound interpretation of PRA) during screening should be <3× ULN and >lower limit of normal (LLN) on the subject’s usual sodium intake (if PRA >2 × ULN and <3 × ULN, subject must have normal age-specific systolic blood pressure and heart rate and serum potassium Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Have a diagnosis of any of the other forms of classic CAH.
•- Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic daily therapy with oral glucocorticoids.
•- Have a clinically significant unstable medical condition or chronic disease other than CAH
•- Have a history of malignancy, unless successfully treated with curative intent and considered to be cured.
•- Have a known history of clinically significant arrhythmia or abnormalities on screening ECG.
•- Have a known hypersensitivity or allergy to any corticotropin-releasing hormone (CRH) receptor antagonist or any component of the study drug.
•- Females who are pregnant or lactating.

发起方

eurocrine Biosciences, Inc.