EUCTR2019-004873-17-DE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 Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment
eurocrine Biosciences, Inc.0 个研究点目标入组 165 人开始时间: 2020年5月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 165
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must provide written informed consent.
- •Be a female or male at least 18 years of age.
- •Have a medically confirmed diagnosis of classic 21-hydroxylase deficiency.
- •Be on a stable, supraphysiologic glucocorticoid dose regimen (defined as >13mg/m2/day in hydrocortisone dose equivalents)that has been stable for at least 1 month prior to screening
- •If treated with fludrocortisone, dose should be stable for at least 1 month prior to screening with an upright plasma renin activity (PRA) during screening range that is not greater than ULN on the subject’s usual sodium intake.
- •Female subjects of childbearing potential with fertile male partners must agree to use contraception consistently from screening until the final study visit or 30 days after the last dose of study drug, whichever is longer. A subject who is not of childbearing potential must meet one of the following:
- •Postmenopausal
- •Permanent sterilization procedure.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Have a known or suspected diagnosis of any of the other forms of classic CAH including 11-ß-hydroxylase deficiency, 17-a-hydroxylase deficiency, 3-ß-hydroxysteroid dehydrogenase deficiency, P450 side-chain cleavage deficiency, or P450 oxidoreductase deficiency.
- •Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic therapy with oral, glucocorticoids, or requiring chronic therapy with inhaled glucocorticoids that based on dose and hormone profile the investigator deems would yield significant systemic exposure interfering with study endpoints.
- •Have a clinically significant medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, significant malabsorption, hematologic, pulmonary, psychiatric, or endocrine disease [excluding CAH]) that in the opinion of the investigator would preclude the subject from participating in and completing the study or that could confound interpretation of study outcome.
- •History of malignancy, unless successfully treated with curative intent and considered to be cured.
- •Have a known history of clinically concerning cardiac arrhythmia (including long QT syndrome) or prolongation of screening (pre-treatment) QT interval corrected for heart rate using Fridericia’s correction (QTcF) of >450 msec (males) or >470 msec (females).
- •Known sensitivity (ie, hypersensitivity) or allergy to any corticotropin-releasing hormone (CRH) receptor antagonist.
- •Have evidence of chronic renal or liver disease
- •Used any active investigational drug in the context of a clinical trial within 30 days or 5 half-lives (whichever is longer) before screening, or plans to use such an investigational drug (other than the study drug) during the study.
- •Females who are pregnant or lactating.
研究者
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