EUCTR2006-002506-58-DE进行中（未招募）1 期
ong-term phase IV multicentre study on the safety and efficacy of Omnitrope® (rhGH) in short children born Small for Gestational Age (SGA)
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
- Sandoz GmbH
- 入组人数
- 240
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. Pre-pubertal (Tanner stage I) children born SGA
- •Boys: equal or above 4 years of age (bilateral testicular volume < 4 ml)
- •Girls: equal or above 4 years of age (bilateral Tanner breast stage 1)
- •2. Growth disturbance defined as current height SDS < -2.5 (and parental adjusted SDS < -1) for chronological age and sex according to country specific references. If country specific references are not available, pre-defined published references will be used.
- •3. Birth weight and/or length below -2 SD for gestational age (according to country specific references). For the evaluation of gestational age, the date of the last menstrual period or ultrasonographic data obtained during the pregnancy should be used. If country specific references are not available, pre-defined published references will be used.
- •4. Height records between 18 months and 6 months prior to the start of GH treatment must be available.
- •5. Calculated height velocity SDS < 0 during the last year according to Prader 1989
- •6. Written informed consent of patient (for children who can read and write) and parent or legal guardian
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •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. Onset of puberty
- •2. Closed epiphyses
- •3. Diabetes mellitus type I or type II
- •4. Fasting blood glucose equal or above 100 mg/dl (equal or above 5.6 mmol/l) measured in venous blood sample
- •5. Abnormal findings in OGTT defined by equal or above 140 mg/dl (equal or above 7.8 mmol/l) after 120 minutes
- •6. Known IGF-I level above +2SD for sex and age
- •8. Acute critical illness e.g. suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure.
- •9. Known to be hepatitis B or hepatitis C positive or HIV-positive, known to have advanced diseases such as AIDS or tuberculosis
- •10. Any other disease, genetic disorder or malformation or treatment known to be associated with growth retardation, e.g. Turner or Noonan syndrome, Laron syndrome, Russell-Silver syndrome, Prader-Willi syndrome, skeletal dysplasias, chronic renal failure, cystic fibrosis, heart and liver diseases, malabsorption (coeliac disease), malnutrition, patients receiving radiation therapy of head or spinal cord
- •11. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- •12. Known or suspected hypersensitivity to rhGH or any of the excipients (e.g. benzyl alcohol)
- •13. Previous treatment with any hGH preparation
- •14. Oral, inhalative or parenteral treatment with glucosteroids, except for physiological replacement, or hypothyroidism which has been left untreated, or was inadequately treated, or treated for less than 3 months
- •15. Treatment with LHRH / gonadotropin releasing hormone (GnRH) analoga (e.g. triptorelin)
- •16. Treatment with antidiabetic medication (e.g. metformin, insulin)
- •17. Drug abuse, substance abuse, or alcohol abuse
- •18. Known to be immunocompromised
- •19. Intake of growth promoting medication, e.g. anabolic steroids
- •20. Use of other investigational drugs within 30 days of enrolment
- •21. Patients unwilling and/or parents/guardians who are not capable of ensuring compliance with the provisions of the study protocol
研究者
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