EUCTR2018-000584-85-DK进行中（未招募）1 期
Effect of insulin sensitization on insulin like growth factor-1 responses to growth hormone treatment in children born small for gestational age - SGA Metformin study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
- •Inclusion Criteria:
- •SGA children eligible for GH treatment according to EMA and NICE criteria
- •Gestational age at birth >28 weeks
- •Age 4-9 years in girls and 4-10 years in boys
- •Prepubertal at start of treatment
- •Naïve to GH therapy
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Inclusion Criteria:
- •SGA children eligible for GH treatment according to EMA and NICE criteria
- •Gestational age at birth >28 weeks
- •Age 4-9 years in girls and 4-10 years in boys
- •Prepubertal at start of treatment
- •Naïve to GH therapy
- •Exclusion Criteria
- •Known or suspected allergy to GH
- •Known or suspected hypersensitivity or allergy to Metformin
- •Previous participation in a GH trial
- •Severe learning difficulties
- •Previous or active malignancy
- •Benign intracranial hypertension
- •Growth failure due to chronic diseases, syndromes, or chromosomal anomalies
- •Cardiac, pulmonary, hepatic or renal diseases associated with significant decompensation
- •Psychological problems likely to lead to significant non-compliance
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