NCT02173821已完成3 期
A Follow-up Study to Examine the Presence of Anti-human Growth Hormone Antibodies Following a Randomised, Open-label, Parallel-group, Multi-centre Trial (FE 999905 CS07) in Which the Efficacy and Safety of 12 Months' Treatment With One Daily Dose of ZOMACTON Were Compared to One Daily Dose of GENOTROPIN
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 9
- 主要终点
- Prevalence of anti-human Growth Hormone (hGH) antibodies
研究概览
简要总结
This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of anti-hGH antibodies at any post-dosing visit during the 12-month treatment period. No investigational medicinal product will be administered in connection with this follow-up study. Eligible patients will attend one visit in this follow-up study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous participation in trial FE 999905 CS07 and presence of anti-hGH antibodies at any post-dosing visit throughout the 12-month treatment period
- •Signed informed consent and obtained assent according to local rules and practice
- •Information on medical history, concomitant medications, and growth hormone therapy since completion of trial FE 999905 CS07
排除标准
- •There are no pre-defined exclusion criteria in this study
结局指标
主要结局
Prevalence of anti-human Growth Hormone (hGH) antibodies
时间窗: At visit 1
Measured as percentage of patients with positive anti-hGH antibodies.
次要结局
- Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples(At visit 1)
- Binding capacity levels in confirmed anti-hGH antibody positive samples(At visit 1)
研究者
研究点 (9)
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