A European, Multi-Centre, Multi-Country, Post-Authorisation, Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Shire
- 入组人数
- 3,258
- 试验地点
- 24
- 主要终点
- Incidence of intercurrent illness
研究概览
简要总结
As a post-approval requirement of the European Medicines Agency, this European patient post authorization safety study is an observational study being conducted to monitor the safety of long-term treatment with Plenadren and other glucocorticoid replacement therapies in routine clinical practice in patients with chronic adrenal insufficiency (primary or secondary).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic adrenal insufficiency
- •Written informed consent/assent in compliance with applicable country-specific and local regulations
排除标准
- •Participation in an interventional clinical trial
结局指标
主要结局
Incidence of intercurrent illness
时间窗: approximately 10 years
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Incidence of adrenal crisis
时间窗: approximately 10 years
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Incidence of serious adverse events
时间窗: approximately 10 years
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
次要结局
未报告次要终点