EUCTR2020-004381-19-ES
进行中（未招募）
1 期
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2021年8月13日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Classic Congenital Adrenal Hyperplasia (CAH)
- 发起方
- eurocrine Biosciences, Inc.
- 入组人数
- 81
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- 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, be on a stable regimen with plasma renin activity (PRA) indicating adequate replacement.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 81
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
排除标准
- •\- 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.
- •\- Females who are pregnant or lactating.
结局指标
主要结局
未指定
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