EUCTR2010-020742-10-FI进行中（未招募）不适用
Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ipsen Pharma
- 入组人数
- 63
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
- •Treatment with rhGH at a minimum starting dose of 0.025 mg/kg/day (without dose reduction) to a maximum dose of 0.035 mg/kg/day for at least 12 months and a maximum of 18 months based on the diagnosis of IGHD with a pre-treatment GH stimulation test/spontaneous maximum of GH < 10µg/L
- •First year of rhGH treatment resulting in height gain < 0.5 SDS
- •Chronological age from 3 to 9 years inclusive for girls, from 3 to 10 years inclusive for boys
- •Pre-pubertal: Tanner stage 1 (Girls: Tanner B1, Boys: Testis = 3ml)
- •Parent(s)/guardian(s) have provided written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 63
- •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
- •Evidence (more than 20% rhGH injections missed) or suspicion of poor compliance during the first year of rhGH treatment
- •Hypothalamic-pituitary tumours or malformations diagnosed or treated prior to screening
- •Any history of cancer and/or evidence of any active malignancy or intracranial tumours
- •Co-morbidity known to affect linear growth including, but not limited to, skeletal dysplasia
- •Chronic illness including but not limited to diabetes, inborn errors of metabolism, osteochondrodystrophy, disorders of genitourinary, cardiopulmonary, gastrointestinal, or central nervous system
- •Any named syndrome known to be associated with short stature but not limited to Prader-Willi syndrome, Russel Silver syndrome, etc.
- •Neurological disease and mental disabilities that may interfere with compliance [Attention Deficit Hyperactivity Disorders (ADHD), autism, Asperger]
- •Ongoing drug treatment known to alter growth, including but not limited to high dose glucocorticoids
- •Multiple hormonal deficiencies except hypothyroidism if corrected and well controlled
- •Clinically significant abnormal findings at previous fundoscopy or echocardiogram, that could be worsened by rhGH and/or rhIGF-1 administration
- •Significant abnormality in clinical screening laboratories, as determined by the Investigator
- •Syndromes that predispose the subject to cancer (e.g. Fanconi syndrome, Bloom syndrome, ataxia telangectasia)
- •Active seizure disorders, defined as one or more seizures per month irrespective of anticonvulsant therapy
- •Known allergy or hypersensitivity to any components of NutropinAq® (somatropin) or Increlex® (mecasermin)
- •Acute critical illness due to complications following open heart or abdominal surgery, multiple accidental traumas or acute respiratory failure
- •Any current or previous exposure to therapeutic spinal irradiation
- •Prior bone marrow transplantation
- •Evidence of clinical malnutrition or growth deficit attributable to emotional deprivation
- •Participation in a clinical trial within the last 12 weeks
- •Any social or medical condition that, in the opinion of the Investigator, would be detrimental to either the subject or the study
研究者
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