NCT00145457已完成4 期
A Multicentre Study on the Capacity of the IGF-1 Stimulation Test to Predict the Growth Promoting Effect of Standard and High Doses of Genotonorm® in Prepubertal Children With Growth Hormone Deficiency.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 82
- 试验地点
- 9
- 主要终点
- Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.
研究概览
简要总结
To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1 changes, on the 24 months growth response to 2 different doses of GH in patients with conventional GH 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
- 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
- •Male or female aged of more than 4 years.
- •GHD defined as a peak GH level < 20 mUI/ml at two different pharmacological GH provocative tests including one done with two pharmacological agents and both performed within the year before the inclusion, according to the current recommendations of the French Health Authorities
排除标准
- •Previous treatment with GH
- •Ongoing pharmacological treatment with steroids except if corresponding to substitutive therapy
结局指标
主要结局
Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.
次要结局
未报告次要终点
研究者
研究点 (9)
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