Modified-release Hydrocortisone Therapy as a Treatment for CAH

改良释放氢化可的松疗法治疗 CAH

• 批准号: 8941563
• 负责人: Deborah Merke
• 金额: --
• 依托单位: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8941563
• 关键词: Adrenal Cortex Diseases; Adrenal Glands; Adrenal gland hypofunction; Aldosterone; Androgens; Biochemical Markers; Circadian Rhythms; Clinical; Clinical Trials; Congenital adrenal hyperplasia; Data; Data Analyses; Dexamethasone; Disease; Drug Delivery Systems; Drug Formulations; Drug Kinetics; Enrollment; Failure; Glucocorticoids; Goals; Growth; Hormone replacement therapy; Hormones; Hour; Hydrocortisone; Infertility; Life; Metabolic syndrome; Obesity; Osteoporosis; Outcome; Participant; Patients; Phase; Pilot Projects; Prednisone; Steroid 21-Monooxygenase; Therapeutic; Time; Virilism; design; improved; novel strategies; programs

This study has completed enrollment of all 16 participants. Pharmacokinetic data has been obtained on all patients. This clinical trial has ended and data analysis is underway. Chronocort is a modified release therapy that delivers hydrocortisone in a manner that mimics the bodys normal circadian rhythm (the bodys natural, 24-hour hormone cycle). This therapeutic approach has the potential to help patients suffering from diseases due to cortisol deficiency: congenital adrenal hyperplasia and adrenal insufficiency. Each of these diseases requires life-long treatment and this novel approach to drug delivery has the potential to significantly improve patients lives.

本研究已完成所有16名受试者的入组。已获得所有患者的药代动力学数据。该临床试验已结束，数据分析正在进行中。Chronocort是一种改良释放疗法，以模仿人体正常昼夜节律（人体自然的24小时激素周期）的方式释放氢化可的松。这种治疗方法有可能帮助患有皮质醇缺乏症的患者：先天性肾上腺皮质增生和肾上腺皮质功能不全。这些疾病中的每一种都需要终身治疗，这种新的药物输送方法有可能显着改善患者的生活。