jRCT2031210491已完成不适用
A randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared with Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over with Congenital Adrenal Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- biochemical responder rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 16age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participant must be aged 16 years or older at the time of signing the informed consent/assent.
- •In participants aged <18 years, height velocity must be less than 2 cm/year in the last year and puberty must be completed (Tanner stage V).
- •Participants with known classic CAH due to 21-hydroxylase deficiency diagnosed in childhood with documented (at any time) elevated 17-OHP and with or without elevated A4 and currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone (or a combination of the aforementioned glucocorticoids) and on stable glucocorticoid therapy for a minimum of 3 months.
- •Participants who are receiving fludrocortisone must be on a documented stable dose for a minimum of 3 months prior to enrollment and must have stable renin levels at screening.
- •Male and female participants.
- •Female participants of childbearing potential and all male participants must agree to the use of an accepted method of contraception during the study.
- •A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least one of the following conditions applies:
- •Not a woman of childbearing potential (WOCBP)
- •A WOCBP with a negative pregnancy test at entry into the study.
- •Note: females presenting with oligomenorrhea or amenorrhea who are aged =< 55 years should be considered potentially fertile and therefore should undergo pregnancy testing like all other female participants.
- •Capable of giving signed informed consent/assent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Clinical or biochemical evidence of hepatic or renal disease e.g. creatinine >2 times
- •the upper limit of normal (ULN) or elevated liver function tests (alanine
- •aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times the ULN).
- •History of bilateral adrenalectomy.
- •History of malignancy (other than basal cell carcinoma successfully treated
- •>26 weeks prior to entry into the study).
- •Participants who have type 1 diabetes, receive regular insulin, have uncontrolled diabetes, or have a screening HbA1c greater than 8%.
- •Persistent signs of adrenal insufficiency or the participant does not tolerate treatment
- •at the end of the 4-week run-in period.
- •Participants with any other significant medical or psychiatric conditions that in the
- •opinion of the Investigator would preclude participation in the study.
- •Participants on regular daily inhaled, topical, nasal or oral steroids for any indication
- •other than CAH.
- •Co-morbid condition requiring daily administration of a medication or consumption
- •of any material that interferes with the metabolism of glucocorticoids (examples
- •provided at http://medicine.iupui.edu/clinpharm/ddis/clinical-table/).
- •Participants who are receiving <10 mg hydrocortisone dose at screening or the
- •hydrocortisone dose equivalent.
- •Participants anticipating regular prophylactic use of additional steroids e.g. for
- •strenuous exercise.
- •Participation in another clinical study of an investigational or licensed drug or device
- •within the 12 weeks prior to screening.
- •Inclusion in any natural history or translational research study that would require
- •evaluation of androgen levels during the study period outside of this protocol's
- •assessments.
- •Participants who have previously been exposed to Chronocort in any Diurnal study.
- •Participants who routinely work night shifts and so do not sleep during the usual
- •night-time hours.
- •Participants, who in the opinion of the Investigator, will be unable to comply with the requirements of the protocol.
- •Participants with a known hypersensitivity to any of the components of the Chronocort capsules, the Cortef tablets, or the placebo capsules.
- •Participants with congenital galactosemia, malabsorption of glucose and galactose, or who are lactase deficient.
- •Participants with a body weight of 45 kg or less.
结局指标
主要结局
biochemical responder rate
时间窗: after 28 weeks of randomized treatment
To compare Chronocort to IRHC in terms of biochemical responder rate
次要结局
- dose responder rate(28 weeks)
- total daily dose(28 weeks)
研究者
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