NCT01342146已完成2 期
Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Growth velocity
研究概览
简要总结
The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have a height less than two standard deviations (SD) below the median height for individuals of the same age or height, a growth velocity (GV) ≤4 cm/yr, a GH peak concentration <7 ng/ml in two different provocative tests, a bone age (BA; ≤9 years in girls and ≤10 years in boys) at least 2 years less than his/her chronological age (CA);
- •be in preadolescence (Tanner stage 1) and have a CA >3 years;
- •have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV;
- •receive no prior GH treatment.
- •sign informed consent
排除标准
- •patients with severe cardiopulmonary
- •patients with hematological diseases
- •a current or past history of malignant tumors
- •immunodeficiency diseases
- •mental diseases
- •patients positive for hepatitis B e-antibody (HBeAb)
- •hepatitis B surface antigen (HBsAg)
- •hepatitis B e antigen (HBeAg)
- •patients with other growth disorders, such as Turner syndrome
- •constitutional delay of growth and puberty, and Laron syndrome
结局指标
主要结局
Growth velocity
时间窗: 25 weeks
次要结局
- height standard deviation score for chronological age (Ht SDSCA)(25 weeks)
- IGFBP3(25 weeks)
- IGF-1(25 weeks)
研究者
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