EUCTR2005-003146-33-SE进行中（未招募）1 期
INDIVIDUALIZED DOSE OF GENOTROPIN® (SOMATROPIN) TO SHORT PREPUBERTAL CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA): COMPARISON WITH FIXED DOSE TREATMENT IN EVALUATION OF GROWTH AND SAFETY IN AN OPEN, PROSPECTIVE, RANDOMIZED MULTI-CENTER TRIAL (IDSGA) - IDSGA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer AB
- 入组人数
- 111
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
- •- Confirmed diagnosis of SGA: Gestational age known and ³30 weeks and birth weight and/or length < -2.0 SDS according to gestational age.
- •- Chronological age at start of somatropin treatment: boys 2.0-9.0 years, girls 2.0-7.0 years of age.
- •- Known parental heights, preferably measured but estimates will be accepted.
- •- Height at screening below –2.5 SDS, with the appropriate Swedish population based reference Karlberg 2002.
- •- GH evaluation (at least 12 hour night profile), not older than 3 years.
- •- Signed written informed consent obtained from both parents/legal guardians of the child, and assent from the child as appropriate.
- •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
- •- Complicating disease, other than correctly treated hypothyroidism, such as celiac disease, neurological disease, hepatic disease, heart or renal failure, dyschondroplacias. Definition of complicating disease as judged by the Investigator.
- •Past or ongoing malignant disease.
- •- Diabetes mellitus Type I, Type II, or OGTT results abnormal at baseline
- •- Concomitant syndromes (i.e. Turner syndrome verified by chromosomal analysis in girls and other syndromes such as bird headed syndrome, Noonan syndrome verified by photo at screening) other than Silver-Russell’s syndrome.
- •- No height catch-up defined as 0 or negative difference between two repeated (first and second) height SDS measurements. Measurements must be performed within 5 and 7 months using the appropriate Swedish population based reference Karlberg 2002. Note; the subject must be at least 2,0 years old at the first measurement
- •- Prior treatment with GH.
- •- Unwillingness to participate in the trial, unable and/or unlikely to comprehend and/or follow the protocol or expected non-compliance
- •- Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry into the study.
- •- Chronic oral glucocorticoid treatment, inhalation steroids (i.e. budesonid > 400 ug or fluticason >200ug)and treatment with hormones other than levothyroxin.
- •- MHP SDS – Height SDS > - 1 SDS screening.
- •- Pubertal signs: girls = Tanner breast stage >B1; boys: Prader testicular volume ³3 mL.
- •- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results, and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
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