A Randomised, Open-label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety for 12 Months of Zomacton to Genotropin in Children With Idiopathic Growth Hormone Deficiency
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 43
- 主要终点
- Height Velocity
研究概览
简要总结
This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone deficiency in children. The children will be treated for 1 year. Half of the patients will be treated with Genotropin and half with Zomacton. During this time they will be dosed every day by themselves or their parents at home in the evening. There will be 138 patients in the trial from age 3 to age 11. The patients cannot have been treated before with growth hormone and the patients must have a proven growth hormone deficiency, this will be shown by a specific test that will be performed before the trial in the local clinic and once during the trial. During the time of the treatment the patients will come to visit the clinic every 3 months. At these visits their heights will be measured, blood samples will be taken, physical examinations will be performed and questions about their health will be asked. At 2 times in the trial they will have a hand x-ray taken to measure the bone age. At the end of the trial the patients will stop the treatment and continue on one of the marketed products available to treat growth hormone deficiency.
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
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Children aged ≤3yrs old and not above 10 yrs for girls or 11 yrs for boys
- •Idiopathic growth hormone deficiency confirmed during the pre-screening period by a standard GH stimulation test (defined as peak level of <10ng/ml pr lower if so required by the country specific board(s)
- •Height SDS <-2 SD of ref value for CA
- •Height velocity SDSCA ≤ 0 SD of ref value for at lease 6 months prior to pre-screening
- •Height recorded for at least 6 months but not more than 18 months of pre-screening
- •The difference between CA-BA≥ 1
- •A positive locally performed GH stimulation test (defined as a peak plasma level of<9ng/ml or lower if so required by the country specific board(s)) prior to the pre-screening
排除标准
- •BA above 9 yrs for girls and 10 yrs for boys
- •Puberty Tanner stage >1
- •Weight <12 Kg at screening
- •Any prior treatment with GH
- •Closed epiphysis
- •Any diagnosed or suspected syndrome (e.g. Silver -Russell, Turner's or seckel syndrome) which possibly could affect growth
- •Any other diagnosed or suspected endocrine or metabolic disorder
- •Any diagnosed or suspected sever chronic disease
- •Clinical signs of dysmorphic features, malformations or mental retardations
- •Growth failure due to other disorders
- •Previous or present use of drugs that could interfere with GH treatment (e.g. steroids)
- •Diagnosed malignant disease
- •Any abnormal CS lab results that requires further investigation
- •Receipt of an investigational drug within the last 28 days preceding screening or longer if considered possible to influence the outcome of the current trial
- •Any knowledge of hypersensitivity to somatropin or any of the excipients of Zomacton or Genotropin
研究组 & 干预措施
1
干预措施: Genotropin (Drug)
2
干预措施: Zomacton (Drug)
结局指标
主要结局
Height Velocity
时间窗: 12 months
次要结局
- BA (Bone Age)(12 months)
- Change in IGF-1 and IGFBP-3(12 months)
- Anti-hGH AB(12 months)
- CS Changes in safety lab, physical examination and vital signs(12 months)
- Height SDS(12 months)
- Height velocity SDS(12 months)
- AE and tolerability(12 months)