EUCTR2014-004104-30-Outside-EU/EEA进行中（未招募）不适用
Treatment With Recombinant Human Growth Hormone (Genotonorm) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •1.Children with JIA or NeS,
- •2.Chronological age (CA) (greater than)> 3 years old,
- •3.Before or during puberty,
- •4.Treated with corticoids for at least 1 year at a dose greater than equal to (>=) 0.2 mg/kg/day equivalent prednisone, IV or orally, daily or alternate day regimen, and were intending to continue corticotherapy with hGH treatment,
- •5.Height less than (<) -2 standard deviation (SD) or loss of 1 SD during the 2 years preceding inclusion in the study,
- •6.Bone age (BA) <13 years for females and; <14 years for males,
- •7.In pubertal subjects B2 =breast development less than equal to (<=) B3 for females and 4 ml <= testicular volume <= 12 ml for males,
- •8.Provided signed informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •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
- •1.Diabetes Type 1 and 2,
- •2.Endocrine disease, except well substituted hypothyroidism,
- •3.Chronic renal diseases with glomerular filtration rate <50 ml/min/1.73 m2,
- •4.Known or suspected allergy to the preservative m-cresol, Non compliant subjects,
- •5.Subjects treated with sexual steroids (estrogens, testosterone) during the 6 months before inclusion in the study,
- •6.Secondary resistance to the treatment of NeS defined by proteinuria with albuminemia <30 grams per liter (g/l) for >3 consecutive months,
- •7.Malignancies,
- •8.Previous human growth hormone (hGH) treatment,
- •9.Inclusion in other study protocol.
研究者
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