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临床试验/EUCTR2004-002507-32-GB
EUCTR2004-002507-32-GB进行中(未招募)1 期

Effect of recombinant growth hormone on growth and chondrocyte dynamics in children with Inflammatory bowel disease (IBD) and growth failure. - rhGH in IBD

Royal Hospital For Sick Children, Yorkhill Division0 个研究点目标入组 60 人开始时间: 2005年2月17日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
60

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 IBD
  • Height Velocity SDS of less than –0.5 over 6 months prior to study.
  • Patients of all ages will be eligible but boys and girls with significant pubertal delay shall only be eligible after a period of treatment with sex steroids
  • Written informed consent
  • 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

  • Previous treatment with rhGH
  • Diabetes mellitus or history of significant glucose intolerance (fasting blood glucose>5.5mmol/l)
  • Endocrinopathy other than GHD
  • Bowel surgery within last 6 months
  • Active malignancy
  • Ongoing anti-cancer therapy
  • Benign intracranial hypertension.
  • Severe arterial hypertension, defined as diastolic blood pressure > 110 mmHg with or without antihypertensive treatment.
  • Known or suspected allergy to the trial product or related products.
  • Lactation/pregnancy or intent to become pregnant during the planned trial period.

研究者

发起方
Royal Hospital For Sick Children, Yorkhill Division

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