Non-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease (Post-Authorization Safety Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 54
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c.
研究概览
简要总结
This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease. Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies will be monitored. For this study, each enrolled patient will be followed up for 3 years after enrollment. Patients who permanently discontinue pasireotide s.c. prior to completing the 3-year observation period will be followed up for 3 months after the last dose of pasireotide s.c.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written informed consent or equivalent document (e.g., written information) as per country regulation prior to registration of any patient data
- •Male or female patients aged 18 years or older with a diagnosis of Cushing's disease for whom surgery has failed or for whom surgery is not an option
- •Patients must be treated with pasireotide s.c. started either at the first visit for this study or prior to study entry
排除标准
- •Patients with ectopic ACTH-dependent Cushing's syndrome
- •Patients with adrenal Cushing's syndrome
- •Patients with Pseudo Cushing's syndrome
研究组 & 干预措施
Cohort 1/new use cohort
Subjects who initiated pasireotide s.c. at time of study entry (on or after the signing of the informed consent or acknowledging an equivalent document -for example, written information- as per country regulation).
干预措施: Pasireotide (Drug)
Cohort 2/prior use cohort
Subjects who initiated pasireotide s.c. prior to study entry.
干预措施: Pasireotide (Drug)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability Profile of Pasireotide s.c.
时间窗: 3-year follow-up
Number of pasireotide s.c related adverse events and serious adverse events, when administered as monotherapy or in combination with other therapies in patients with Cushing's disease
次要结局
未报告次要终点