NCT02020499终止不适用
Non-interventional, Observational, Long Term Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel (ATG) Treatment in Patients With Acromegaly.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 5
- 试验地点
- 5
- 主要终点
- Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
研究概览
简要总结
This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly.
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
- •Diagnosis of Acromegaly.
- •Males and females aged 18 years and older.
- •Signed informed consent (patient must give consent to the collection of retrospective data).
- •Patients who have had surgery may enter the study 3 months post-surgery and evaluated for the duration of the study.
- •With the intention to be treated with ATG (decision to prescribe ATG made prior to inclusion into the study) or already being treated with ATG.
- •If already being treated with ATG:
- •Previous ATG treatment maximum of 3 months. AND Minimum data available (demographic data, disease history including previous treatments, GH, IGF-1 levels at baseline and under treatment as applicable).
- •Not receiving Dopamine Agonists or other medical therapy (Pegvisomant, or other somatostatin analogues) for the treatment or symptom control of acromegaly.
排除标准
- •The subject has had radiotherapy in the last 5 years.
- •The subject has had surgery in the last 3 months.
- •The subject has already been included in this study.
- •Participation in an interventional trial, or receiving experimental drug.
研究组 & 干预措施
Acromegalic patients
Acromegalic subjects treated with Somatuline Autogel® (Lanreotide)
干预措施: Somatuline Autogel® (lanreotide) 60, 90, 120 mg. (Drug)
结局指标
主要结局
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
时间窗: Baseline and 4 weeks
次要结局
- Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline(Baseline, 1 year and 3 years)
研究者
研究点 (5)
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