IRCT20150303021315N12招募中3 期
A randomized, two-armed, parallel, active-controlled clinical trial to compare equivalent efficacy along with safety, and immunogenicity of CinnaTropin® (CinnaGen, Iran) to Norditropin® NordiLet® (Novo Nordisk, Denmark) in pre-pubertal children with growth hormone deficiency (GHD)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 3 years 至 10 years（—）
- 性别
- All
入选标准
- •Prepubertal (Tanner stage I)
- •3 to 10 years of age for male children and 3 to 8 years of age for female children
- •Isolated idiopathic growth hormone deficiency diagnosed
- •Peak growth hormone value of <10.0 µg/l following two recommended growth hormone stimulation tests
- •Height Standard Deviation Score (HSDS) = -2.0 and Height Velocity Standard Deviation Score (HVSDS) =-1.0; or HSDS = -3.0
- •The ratio of bone age to chronological age < 0.9
- •Full-term birth weight above 2500 g
- •Euthyroid state
排除标准
- •Chronic systemic disease, such as diabetes mellitus or renal disease
- •Evidence of active tumor
- •Chromosomal or skeletal abnormalities
- •Signs of idiopathic intracranial hypertension
- •Closed epiphyses
- •Chronic use of oral or parenteral glucocorticoid in the past three months
- •Using methylphenidate in the last 14 days
研究者
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