NCT01333384已完成不适用
A Non-Interventional Retrospective (12 Months) and Prospective (at Least 24 Months) Resource Utilization Study, in the Population of Polish Acromegalic Patients Treated With Somatuline Autogel at Normal (4 Weeks) or Extended (6 or 8 Weeks) Dosing Interval
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage variation of Insulin-like growth factor-1 (IGF-1) levels
研究概览
简要总结
The purpose of this study is to evaluate over the 24 month prospective follow up - in everyday clinical practice - resource utilization and effectiveness of the treatment of acromegalic patients in Poland with Somatuline Autogel 120 mg including extended injection intervals.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Adult patients with acromegaly treated for at least three injections with Somatuline Autogel 120 mg
- •Subjects must be treated for acromegaly for at least 1 year, with medical treatment prior to inclusion. One year historical data must be available
排除标准
- •Active participation in any interventional or any other non-interventional acromegaly clinical study. Previous participation in observational / post-marketing study of other somatostatin analogue should not be an exclusion criteria
结局指标
主要结局
Percentage variation of Insulin-like growth factor-1 (IGF-1) levels
时间窗: 24 months
次要结局
- Proportion of patients with GH levels below 1.0 microgram/liter(24 months)
- Mean growth hormone (GH) levels(24 months)
研究者
研究点 (1)
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