Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 98
- 试验地点
- 19
- 主要终点
- Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population
研究概览
简要总结
To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Glucocorticosteroid treatment for 12 months at least
- •Bone age < 15 years for a boy and < 13 years for a girl
- •Child measured height < - 2 SD, Child currently treated by GH
排除标准
- •Known diabetes (type 1 or type 2)
- •A previous history of intolerance or hypersensitivity to the study drug or to drugs with similar chemical structures
研究组 & 干预措施
Somatropin
干预措施: Somatropin (Drug)
结局指标
主要结局
Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population
时间窗: Baseline, Month 36
Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.
Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population
时间窗: Baseline, Month 36
Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.
次要结局
- Mean Height(Baseline, Month 12, 24, 36, 48, 60)
- Mean Height Standard Deviation Score (SDS) for Bone Age (BA)(Baseline, Month 12, 24, 36, 48, 60)
- Annual Growth Rate (AGR)(Baseline, Month 12, 24, 36, 48, 60)
- Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA)(Month 12, 24, 36, 48, 60)
- Body Mass Index (BMI)(Baseline, Month 12, 24, 36, 48, 60)
- Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA)(Baseline, Month 12, 24, 36, 48, 60)
- Change From Baseline in Height at Month 12, 24, 36, 48 and 60(Baseline, Month 12, 24, 36, 48, 60)
- Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60(Baseline, Month 12, 24, 48, 60)
- Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60(Baseline, Month 12, 24, 36, 48, 60)
- Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60(Baseline, Month 12, 24, 36, 48, 60)
- Ratio of Bone Age (BA) to Chronological Age (CA)(Baseline, Month 12, 24, 36, 48, 60)