NCT01778023已完成3 期
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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Height Velocity (Ht-V)
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
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 below 4 mL in males
- •Growth hormone level above 10 ng/mL following a stimulation test (test result within 6 months from screening can be used)
- •Height below 3 percentile
- •Bone age below or equal to 12 year
- •Epiphyses confirmed as open in patients at least 10 years or more of age
排除标准
- •Known presence of one or more pituitary hormone deficiencies (ACTH (adrenocorticotropic hormone), ADH (antidiuretic hormone), FSH (follicle-stimulating hormone), LH (luteinising hormone), TSH (thyroid-stimulating hormone))
- •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
- •Active malignancy, CNS (central nervous system) trauma, active chemotherapy or radiation therapy for neoplasia
- •Prior history of intracranial hypertension
- •Hypertrophic cardiomyopathy
研究组 & 干预措施
hGH:12months treatment
Experimental
干预措施: somatropin (Drug)
hGH: 6 month un-treatment + 6 month treatment
Active Comparator
干预措施: somatropin (Drug)
结局指标
主要结局
Height Velocity (Ht-V)
时间窗: After 6 months of treatment
Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk.
次要结局
- Ht-V (Height Velocity)(At the first 6 months and the last 6 months in group A)
- Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3)(After 6 months of treatment.)
- Change in Ht-SDS (Height Standard Deviation Score)(After 6 months of treatment.)
- Change in Bone Age(After 6 months of treatment.)
- Occurrence of Adverse Events(Throughout the trial (12 months))
- Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I)(After 6 months of treatment.)
研究者
研究点 (1)
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