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临床试验/EUCTR2009-015739-34-DE
EUCTR2009-015739-34-DE进行中(未招募)不适用

Status of the growth hormone/ insulin-like growth factor-1 (GH/IGF-1) axis in relation to growth failure, body weight and neuroprotection in children with Ataxia telangiectasia (AT) - Growth hormone in AT (GHAT)

Goethe-Universität Frankfurt/Main0 个研究点开始时间: 2009年9月14日最近更新:
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

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

  • diagnosis of AT
  • no fusion of epiphyses/closed growth plates determined by X-ray of left wrist and hand (special skeletal age film)
  • age between 3 years to 18 years and no completed puberty
  • growth failure: height below the 10th percentile for chronological age
  • growth failure, defined as growth velocity (measured as linear growth) less than 5% to 10% of that expected for children of the same age group, over the past 12 months
  • provide evidence of serum IGF-1 level performed within the preceding 6 months and the results fall below normal limits for age
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • 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

  • fusion of epiphyseal plates
  • age under 3 years or completion of puberty
  • serum IGF-1 level that is within normal limits for age
  • be above the 10th percentile height for chronological age
  • history of anaphylactic reaction or hypersensitivity to one of the GH formulation
  • any active or suspected neoplasia
  • signs of intracranial hypertension as evidenced by papilledema

研究者

发起方
Goethe-Universität Frankfurt/Main

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