EUCTR2018-001522-25-GB进行中（未招募）1 期
A phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing’s disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Recordati AG
- 入组人数
- 12
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. Male and female children and adolescents from 6 to < 18 years of age with Cushing’s disease of endogenous origin who have failed surgery or are awaiting surgery or for whom surgery is not an immediate option
- •2. Body weight greater than 30 kg
- •3. Confirmed diagnosis of Cushing’s disease
- •4. Able to swallow study drug tablets (not crushed or split)
- •5. Parents or legal guardians able to provide consent/assent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Macroadenoma complicated by compressive symptoms
- •2. Insufficient washout period from any other medication used to lower cortisol levels
- •3. Use of other investigational drugs at the time of enrollment
- •4. History of hypersensitivity to drugs of the same or similar chemical classes as osilodrostat
- •5. History of malignancy of any organ system
- •6. Moderate to severe renal impairment
- •7. Serum ALT and/or AST > 3 x ULN, or total bilirubin > 1.5 x ULN
- •8. History of thrombosis
- •9. Risk factors for QTc prolongation or Torsade de Pointes
- •10. Hypertensive patients with uncontrolled blood pressure
- •11. Patients who have undergone any major surgery within 1 month
- •12. Patients who have undergone trans-sphenoidal pituitary surgery within 6 weeks prior to screening, unless they have clear evidence of persistent hypercortisolemia or persistent biochemical changes consistent with Cushing's disease
- •13. Use of or anticipated use of systemic glucocorticoid medications 1 month prior to screening.
- •14. Uncontrolled hyperthyroidism
- •15. Diabetic patients with poorly controlled diabetes as evidenced by
- •HbA1c > 8.5 % or not optimally treated for diabetes mellitus as judged
- •by the investigator
- •16. Positive pregnancy test in females of childbearing potential
- •17. Female patients of childbearing potential who do not agree to use
- •highly effective birth control methods
- •18. Pregnant or nursing (lactating) women.
- •19. Any medical condition that would, in the investigator's judgment,
- •prevent the patient's participation in the clinical study due to safety
- •concerns or compliance with clinical study procedures.
研究者
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