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Small stature secondary to growth hormone insufficiency deficiencyTherapeutic area: Diseases [C] - Hormonal diseases [C19]
相关药物Omnitrope
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Small stature secondary to growth hormone insufficiency deficiency
- 发起方
- Sandoz SAS
- 入组人数
- 100
- 状态
- 进行中（未招募）
- 最后更新
- 10年前
概览
简要总结
暂无简介。
研究者
入排标准
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
结局指标
主要结局
未指定
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