NCT01605331已完成4 期
Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.)
LG Life Sciences0 个研究点目标入组 132 人开始时间: 2009年12月最近更新:
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
- 入组人数
- 132
- 主要终点
- Safety
研究概览
简要总结
As studies demonstrate, the administration of recombinant human GH (rhGH) in adults with GH deficiency has been known to improve metabolic impairment and quality of life. Patients, however, do have to tolerate daily injections of GH (rhGH).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged ≥ 20 years with diagnosed GH deficiency (caused by pituitary tumor, trauma, other pituitary disease)
排除标准
- 未提供
研究组 & 干预措施
sustained-release recombinant human GH (SR-rhGH)
Experimental
12-week subcutaneous administration, 2mg/week
干预措施: sustained-release recombinant human GH (SR-rhGH) (Drug)
结局指标
主要结局
Safety
时间窗: 12 weeks
Adverse event
次要结局
- Efficacy(12 weeks)
研究者
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