NCT01109017已完成不适用
A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 387
- 主要终点
- Number and type of suspected serious adverse drug reactions (SADRs) during the study period
研究概览
简要总结
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.
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
- •Severe adult growth hormone deficiency
排除标准
- •Known or suspected allergy to study product(s) or related products
- •Previous participation in the study
- •Diabetes Mellitus
- •Presence of malignant tumor(s)
- •Pregnant or likely to get pregnant
研究组 & 干预措施
Norditropin®
干预措施: somatropin (Drug)
结局指标
主要结局
Number and type of suspected serious adverse drug reactions (SADRs) during the study period
时间窗: after 5 years
次要结局
- Number of impaired glucose tolerance events during the study period(evaluated after 3 months, 6 months, 1 year and between 2-5 years)
- Number of other types of adverse events (AEs) during the study period(evaluated after 3 months, 6 months, 1 year and between 2-5 years)
- Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density)(evaluated after 3 months, 6 months, 1 year and between 2-5 years)
- Effects of insulin-like growth factor-1 (IGF-I) levels(evaluated after 3 months, 6 months, 1 year and between 2-5 years)
研究者
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