A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm
研究概览
简要总结
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
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
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronological age (CA) between 3 and 10 for girls
- •Chronological age between 3 and 12 for boys
- •Height for CA below - 2 SD
- •Birth length for CA below -2SD
排除标准
- •Endocrine disease except well-substituted hypothyroidism
- •Sever chronic disease
- •Skeletal dysplasia
- •Known chromosomal aberration
- •Ongoing treatment with steroids
- •Known intrauterine infection
研究组 & 干预措施
Genotonorm A
Continuous 0.7 IU/kg/week or 0.03 mg/kg/day
干预措施: Genotonorm (Drug)
Genotonorm B
Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day
干预措施: Genotonorm (Drug)
Genotonorm C
Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day
干预措施: Genotonorm (Drug)
结局指标
主要结局
Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm
时间窗: Baseline, 2 years
Annual growth rate was expressed as height velocity (centimeter \[cm\]/year). This was derived by substracting annual growth rate at Baseline from 2-year value. (Annual growth rate was calculated each year and rescaled to 1 year if the interval between x and x-1 was not 365 days, as long as a subject remains in the study): ANGRYx = (Height Yx - Height Y{x-1}) / {(Date of Yx - Date of Y{x-1}) /365.25}
次要结局
- Annual Growth Rate Standard Deviation Score (SDS)(Baseline, 1 to 6 years)
- Change From Baseline in Annual Growth Rate SDS(Baseline, 1 to 3 years)
- Height (cm)(Baseline, 1 to 6 years, final height)
- Change From Baseline in Height (cm)(Baseline, 1 to 6 years, final height)
- Height (SDS)(Baseline, 1 to 6 years, final height)
- Change From Baseline in Height (SDS)(Baseline, 1 to 6 years, final height)
- Body Mass Index (BMI)(Baseline, 1 to 6 years)
- Weight(Baseline, 1 to 6 years)
- Change From Baseline in Bone Age(Baseline, 1 to 3 years)
- Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio(1 to 3 years)
- Chronological Age at Onset of Puberty(Onset of puberty)
- Number of Subjects Reaching Puberty(Baseline, 1 to 6 years)