NCT00156143已完成3 期
GH Therapy in Partial GHD Adolescents : Evaluation of Efficacy Based on Body Composition and Comparison of 2 Different Doses of Genotonorm®. Open-Label, Randomised, Comparative, Controlled, Parallel-Group, Multi-Center Phase IIIB Clinical Trial.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 90
- 主要终点
- Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.
研究概览
简要总结
To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation.
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
- 15 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females : Chronological age > or = 15 years and < or = 20 years for females
- •Chronological age > or = 17 years and < or = 20 years for males
- •GHD of childhood onset treated for at least 2 years
- •Last GH injection at least 12 months before baseline visit
排除标准
- •Turner's syndrome
- •Chronic hepatic impairment as shown by GGT and / or ASAT and / or ALAT > 2 X ULN
结局指标
主要结局
Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.
次要结局
未报告次要终点
研究者
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