EUCTR2005-000042-37-SE进行中（未招募）不适用
orditropin Treatment in Subjects with Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The present inclusion criteria are
- •Informed consent before any trial related activities
- •Participation in the original Norditropin® study (S/GHD/004/NOO) or following the protocol for S/GHD/004/NOO without being randomised in the trial
- •The original inclusion criteria were
- •Verbal informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- •Children with Noonan Syndrome. The diagnostic criteria will be
- •oShort stature
- •oHypertelorism
- •oLow set ears
- •oAnd one of the following criteria:
- •?Cubiti valga
- •?Testicular dysplasia
- •?Hypogonadotroph hypogonadism
- •Bone age determination showing no significant acceleration (more than one year above chronological age) according to Greulich and Pyle (14). Patients showing an accelerated bone age (> chronological age) at the first examination will be reevaluated within 6 weeks before treatment start in order to evaluate the development process
- •Age at start of the treatment
- •Age: 3.00-11.99 years
- •Prepubertal according to Tanner standards:
- •< stage 2 with testes < 4 ml (boys) and no breast development (girls)
- •Height < -2 SD of the used Swedish National growth standards (15)taranger
- •Height velocity below 1 SD during the 12 months pre-treatment period (15)
- •Normal thyroid function
- •Normal karyotype
- •Available height data since birth
- •Parent heights available
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The original exclusion criteria were
- •Earlier or ongoing treatment with growth hormone, anabolic steroids or corticosteroids
- •Subjects with congenital heart defect perceived to possibly have a major impact on growth
- •History of or actual endocrine, metabolic or other serious chronic disease perceived to possibly have a major impact on growth
- •Fasting blood glucose consistently above 6.7 mmol/l
- •Growth hormone deficiency defined as
- •oGH levels below 10 µg/l during two consecutive GH stimulation tests
研究者
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