NCT05633953已完成不适用
A Retrospective Observational Study to Evaluate the Safety and Effectiveness of Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome (LINC7)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Effectiveness of Osilodrostat
研究概览
简要总结
This is a multi-centre, observational, non-comparative, retrospective cohort study designed to evaluate the long-term safety and effectiveness of osilodrostat in non-CD CS patients. Patients treated with oral osilodrostat regardless of the duration of their treatment will be followed retrospectively for up to 36 months after initiating osilodrostat.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients ≥18 years old with diagnosis of CS, except for CD (i.e., an aetiology of adrenal adenoma, adrenocortical carcinoma, adrenal hyperplasia, or ectopic adrenocorticotropic hormone secretion). Patients should have a contemporaneously documented diagnosis of CS as per effective guidelines.
- •Patients treated with osilodrostat between April 2019 and study start date as part of ATU programme or commercialisation.
排除标准
- •Patients who participated in a clinical trial anytime during the study period.
- •Patients with Pseudo-Cushing's syndrome, cyclic CS, or iatrogenic CS.
结局指标
主要结局
Effectiveness of Osilodrostat
时间窗: at week 12
Number and proportion of patients with Mean Urinary Free Cortisol (mUFC) ≤ upper limit of normal (ULN)
次要结局
- Long-term Effects of Osilodrostat on Composite Cortisol Measure(At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72)
- Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC)(at weeks 18, 24, 36, 48, 60, and 72)
- Long Term Effects of Osilodrostat on Morning Serum Cortisol(At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72)
研究者
研究点 (1)
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