EUCTR2015-002613-30-Outside-EU/EEA进行中（未招募）不适用
A 12-month, open-labelled, randomised, parallel-group, multi-centre, interventional trial to evaluate the efficacy and safety of recombinant human growth hormone (hGH) (Norditropin® Nordilet®) therapy on height velocity (Ht-V) in patients with idiopathic short stature in Korea
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
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
- •· Informed consent obtained from subject’s parents or legally acceptable representative before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- •· Pre-pubertal status (males aged from 4 to 11 [both inclusive], females aged from 4 to 9 [both inclusive]): an absence of breast development in females (Tanner 1 only) and testicular volume < 4 mL in males
- •· Height below 3 percentile†
- •· Epiphyses confirmed as open in patients =10 years of age
- •· Growth hormone level above 10 ng/mL following a stimulation test (test result within 6 months from screening can be used)
- •· Bone age = 12 years
- •†:According to the 2007 Korean National growth chart (see Appendix D)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 54
- •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
- •· Known presence of one or more pituitary hormone deficiencies (ACTH, ADH, FSH, LH, TSH)
- •· Known primary hypothyroidism, adrenal insufficiency or hypogonadism (treated or untreated)
- •· Specific types of growth failure including, but not limited to, known chromosomal abnormalities associated with growth failure and altered sensitivity to growth hormone
- •· Bone age is advanced over chronological age more than 3 years (inclusive)
- •· Active malignancy, CNS trauma, active chemotherapy or radiation therapy for neoplasia within 5 years prior to screening (Visit 1)
- •· Prior history of intracranial hypertension
- •· Hypertrophic cardiomyopathy
研究者
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