EUCTR2021-004467-26-FR进行中（未招募）1 期
A Phase 3 Open-label Extension Study to Evaluate the Long-term Safety andTolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over with Congenital Adrenal Hyperplasia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 181
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
- •1. Participants with CAH who have successfully completed Chronocort study DIUR-006 (sites in France and US only) or study DIUR-014.
- •2. Participants who are 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 141
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Medical Conditions
- •1. Participants with 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).
- •2. Participants with a history of malignancy (other than basal cell carcinoma successfully treated >26 weeks prior to entry into the study).
- •3. Participants with a history of bilateral adrenalectomy.
- •4. Participants with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the study.
- •Prior/Concomitant Therapy
- •5. Participants with a co-morbid condition requiring daily administration of a medication or consumption of any material that interferes with the metabolism of glucocorticoids (examples at http://medicine.iupui.edu/clinpharm/ddis/clinical-table/).
- •6. Participants on regular daily inhaled, topical, nasal, or oral steroids for any indication other than CAH.
- •7. Participants anticipating regular prophylactic use of additional steroids e.g., for strenuous exercise.
- •Prior/Concurrent Clinical Study Experience
- •8. Participation in another clinical study of an investigational or licensed drug or device within 3 months prior to inclusion in this study, except for another clinical study with the current formulation of Chronocort.
- •Other Exclusions
- •9. Females who are pregnant or lactating.
- •10. Participants, who in the opinion of the Investigator, will be unable to comply with the requirements of the protocol.
- •11. Participants who routinely work night shifts and so do not sleep during the usual night-time hours.
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