EUCTR2015-002802-34-Outside-EU/EEA进行中（未招募）不适用
Multicentre study to evaluate the efficacy and safety of a liquid formulation of recombinant growth hormone, Omnitrope® 3.3mg/mL, in the treatment of pre-pubertal children of small stature suffering from somatotropin deficiency (GH) – phase IIIb
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Sandoz SAS
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Small stature due to growth hormone deficiency
- •Age: girls of under 10 years of age and boys of under 12
- •Height = -2 SD or < -1.5 SD with slow Growth Rate (GR < -1 SD or < 4 cm/year)
- •Weight in line with statural age ± 2SD
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior or current treatment with GH
- •Presence of an active tumour; a lapse of at least 12 months will be required since tumour treatment
- •Current corticosteroid treatment other than substitution treatment or use of an inhaled corticosteroid
- •Insulin-dependent diabetes (according to the WHO definition), or other chronic, severe disease
- •Small stature for other reasons than growth hormone deficiency
- •Peutz-Jeghers syndrome or a family history of colon cancer
研究者
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