NCT00351221终止2 期
A Phase 2, Open-Label, Multicenter, Clinical Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 in Children With Growth Failure Due to Noonan Syndrome
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 3
研究概览
简要总结
The trial will investigate the treatment of growth failure in children with Noonan syndrome. Abnormalities in the growth hormone (GH) - insulin-like growth factor-I (IGF-I) axis resulting in low IGF-I levels have been suggested as a possible cause of short stature seen in Noonan syndrome children. Administration of our investigational product is intended to bypass the abnormalities in the GH-IGF axis, and hopefully improve body growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of Noonan syndrome
- •Height less than the 3rd percentile for age and sex (height SDS < -1.88)
- •Basal IGF-I less than the mean for age and sex (IGF-I SDS < 0)
- •Chronological age greater than 2 years
- •Bone age ≤ 11 years for boys, and ≤ 10 years for girls
- •Pre-pubertal
- •Documented pre-treatment height velocity less than the mean for age and sex
排除标准
- •Clinically significant diseases
- •Chronic illnesses
- •Prior treatment with rhIGF-1
研究者
研究点 (3)
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