EUCTR2007-003949-32-BE进行中（未招募）1 期
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11月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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 19-35 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 (19-35 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).
研究者
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