EUCTR2007-003949-32-AT进行中（未招募）不适用
A two-year multi-centre, randomized two arm study of Genotropin treatment in very young children born small for gestational age: Early Growth and Neurodevelopment (EGN) - Not Applicable
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK0 个研究点目标入组 88 人开始时间: 2007年12月11日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
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
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1. Caucasian male or female subjects aged between 19-29 months at Screening Visit 1.
- •2. Signed and dated informed consent.
- •3. Born SGA (birth length and/or weight <-2 SD for gestational age, using country-specific standards).
- •4. Height below -2.5 SD at screening (19-29 months of age).
- •5. At least one measurement of length between 12 and 18 months of age.
- •6. Normal karyotype in girls to exclude Turners syndrome.
- •7. Screening laboratory values within normal limits, or abnormalities clinically insignificant in the judgement of the investigator.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •Subjects presenting with any of the following will not be included in the study:
- •1. Severe Intra-Uterine Growth Retardation (IUGR) (birth length below - 4 SD for gestational age), if associated with dysmorphic features.
- •2. Severe prematurity (Gestational Age (GA) <32 weeks of gestation).
- •3. Ongoing catch-up growth (defined as growth velocity SDS at inclusion >0) based on at least 4 months measurement interval).
- •4. Severe familial short stature defined as: Father’s height below 155 cm or mother’s height below 145 cm.
- •5. Defined neurological defects and/or severe neurodevelopmental delay.
- •6. Defined syndromes such as fetal alcohol syndrome.
- •7. Severe perinatal complications like asphyxia, sepsis, Necrotizing Enterocolitis (NEC), respiratory distress syndrome, if associated with long-term sequelae (like short bowel syndrome, Broncho Pulmonary Dysplasia (BPD), cerebral palsy etc).
- •8. Other specific reason for short stature (eg, osteochondrodysplasia).
- •9. Any severe, acute or chronic illness (neurological, respiratory, gastrointestinal (eg, Coeliac disease etc) which in the opinion of the investigator may interfere with the interpretation of safety or efficacy evaluations.
- •10. Will be unlikely to comply with the protocol eg, inability to return for follow-up visits, or is unlikely to complete the study.
- •11. Is participating in any other studies involving investigational or marketed products.
- •12. Is currently treated with systemic glucocorticoids or has been treated with glucocorticoids for a period of one week or longer in the past 6 months. Topical or inhaled corticosteroids are permitted.
- •13. Subjects receiving other hormone treatment are not eligible for this study (except stable thyroid hormone replacement).
- •14. Any patient who meets any contraindication specified in the Genotropin SmPC, such as hypersensitivity to the active substance or to any of the excipients or any evidence of tumor activity.
研究者
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