NCT00455884已完成不适用
International Cooperative Metabolic Study (iNCMS) of NutropinAq® [Somatropin (rDNA Origin) Injection] Replacement Therapy in Adults With Growth Hormone Deficiency
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
- 546
- 试验地点
- 1
- 主要终点
- Incidence of serious adverse events
研究概览
简要总结
This study is a multicenter, open-label, observational, post marketing surveillance program to collect information on the use of NutropinAq® in adults suffering from Growth Hormone Deficiency in Germany, Italy, and United Kingdom
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Growth Hormone Deficiency
- •Patients treated with NutropinAq®
- •Patients having completed growth (fused epiphyses)
排除标准
- •Active neoplasia
- •Pregnancy
结局指标
主要结局
Incidence of serious adverse events
时间窗: when reported
次要结局
- Incidence of targeted adverse events, including adrenal insufficiency, arthritis, carpal tunnel syndrome, intracranial hypertension, new onset and recurrence of leukemia & tumor, pancreatitis, peripheral edema requiring medical intervention and death(when reported)
- Incidence of fractures(when reported)
- Incidence of intercurrent cardiovascular events(when reported)
研究者
研究点 (1)
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