NCT00184691已完成3 期
Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone Which Will be Started Randomly at the Ages of 2 to 5, in Children Diagnosed of IUGR
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 13
- 主要终点
- Effect on Efficacy: Height SDS for chronological age
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.
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
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IUGR defined as birth length and/or weight below the lower limit (< P10) of the Lubchenco curves for the gestational age.
- •Chronological age = 2-5 years
- •HV below average for CA
- •Insufficient catch-up growth (Height < P3 for chronological age, according to Hernández)
- •Parental height greater than or equal to -2 SDS of average, that is, 160 cm or more for the father and 148 cm or more for the mother
- •Normal response to GH stimulation test (greater tan or equal to 10 ng/mL)
- •Bone age (measured through Greulich and Pyle method) less than or equal to CA
排除标准
- •Children born from multiple pregnancy
- •Children with post-ischemic encephalopathy
- •Recorded malformative syndromes associated to short stature (Silver-Russell, Rubinstein Taybi, Seckel etc.)
- •Any metabolic or endocrinological disorder (diabetes mellitus, diabetes insipidus, congenital metabolic disorders, with the exception of thyroid diseases corrected by replacement therapy)
- •Any type of growth retardation associated to infections, embryopathies or severe chronic diseases (hemopathies, hepatopathies, malabsorptive pathology, neurologic alterations....)
- •Nutritional disorders (celiac disease) or osteodystrophies
- •Patients who receive or received any treatment (anabolic drugs, sex steroids, etc.) likely to interfere with GH effects
- •Abnormal karyotype
- •Neoplasms
- •Previous or ongoing chemotherapy and/or irradiation
- •Renal dysfunction, defined as serum creatinine > 1 mg/dL
结局指标
主要结局
Effect on Efficacy: Height SDS for chronological age
时间窗: after 48 months
Safety: Bone maturation and glucose metabolism
次要结局
- Efficacy: Height SDS for bone age; Height velocity SDS for bone age; Height velocity SDS for chronological age; Serum IGF-I and IGFBP-3 levels
研究者
研究点 (13)
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