NCT01859949已完成4 期
Long Term Study Of Pnu-180307 For Short Children Born Small For Gestational Age (Sga) Without Epiphyseal Closure (Extension Of The Study 307-met-0021-002)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 62
- 试验地点
- 19
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
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
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with short stature due to SGA who received treatment in the study GENASG-0021-002.
排除标准
- •Children who have any chronic disease requiring treatment with steroid hormone that may affect growth promotion including estrogen, androgen, anabolic hormone, and corticosteroids (except those for external use), and have received the treatment.
- •Children who have received radiotherapy or chemotherapy.
- •Children who have serious cardiac disease, renal disease, or hepatic disease.
- •Children who have diabetes mellitus with a manifestation of abnormal glucose metabolism.
- •Children who have serious chronic disease.
- •Children who have malignant tumor.
- •Children who are allergic to m-cresol.
研究组 & 干预措施
Genotropin (somatropin)
Experimental
干预措施: Genotropin (somatropin) (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Month 12 (at the end of previous study) to 156
次要结局
- Height SDS for Chronological Age(Month 12 (at the end of previous study) to 156)
- Height Velocity SDS for Bone Age(Month 12 (at the end of previous study) to 156)
- Height Velocity Standard Deviation Score (SDS) for Chronological Age(Month 12 (at the end of previous study) to 156)
- Height Velocity(Month 12 (at the end of previous study) to 156)
- Height SDS for Bone Age(Month 12 (at the end of previous study) to 156)
研究者
研究点 (19)
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