NCT00256126已完成4 期
A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children Treated With SAIZEN®
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 2
- 主要终点
- Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1
研究概览
简要总结
The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One of the following diagnoses and candidacy for SAIZEN® therapy:
- •A) GHD: documented pre-established diagnosis of GHD with a growth hormone (GH) peak response of <10 microgram per liter (mcg/L) with 2 GH stimulation tests, without priming with oestradiol.
- •B) Turner syndrome: documented pre-established diagnosis by karyotype.
- •Prepubertal status according to Tanner Pre-established history of normal thyroid function or adequate substitution for at least 3 months.
- •Weight for stature within the population specific normal range (>5th and <95th percentiles) for gender Willingness and ability to comply with the protocol for the duration of the study.
- •Parent's or guardian's written informed consent, given before any study related procedure that is not part of the subject's normal medical care, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough to read and write, a separate assent form will be given.
排除标准
- •Acquired GHD due to central nervous system tumour, trauma, infection, infiltration (documented by imaging), and history of irradiation or cranial surgery
- •Previous treatment with GH, growth hormone-releasing hormone (GHRH), anabolic steroids or any treatment affecting growth.
- •Previous treatment with corticosteroids, except in case of topical or inhaled corticosteroid administration for atopic disease. Corticosteroids for hormonal substitution are also allowed if the condition and the treatment regimen have been stable for at least 3 months.
- •Severe associated pathology affecting growth such as malnutrition, malabsorption, or bone dysplasia.
- •Chronic severe kidney disease.
- •Chronic severe liver disease.
- •Chronic infectious disease.
- •Acute or severe illness during the previous 6 months.
- •Significant concomitant illness that would interfere with participation or assessment in this study.
- •Active malignancy (except non-melanomatous skin malignancies that have undergone surgical excision and/or biopsy, diagnosis and treatment to resolution)
- •History or active Idiopathic intra-cranial hypertension (benign intracranial hypertension or pseudo-tumor cerebri).
- •Diabetes Mellitus type I & II.
- •Any autoimmune disease.
- •Previous screening failure in this study.
- •Use of an investigational drug or participation in another clinical study within the last three months.
研究组 & 干预措施
Turner Syndrome (TS)
Experimental
干预措施: Saizen (Drug)
Growth Hormone Deficiency (GHD)
Experimental
干预措施: Saizen (Drug)
结局指标
主要结局
Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1
时间窗: Baseline, Month 1
IGF-1 SDS was calculated using the Elmlinger reference method. Change in within subject IGF-1 levels (standard deviation scores) at Month 1 from Baseline was assessed. Descriptive statistics were determined for the Baseline and Month 1 assessments, and also for the level of change between these two assessments. If either the Baseline or Month 1 IGF-1 level was missing, then the within-subject change in IGF-1 was assumed to be missing.
次要结局
- Change From Baseline in Insulin-like Growth Factor Binding Protein - 3 (IGFBP-3) Level at Month 1(Baseline, Month 1)
- Change From Baseline in Fasting Insulin Levels at Month 1(Baseline, Month 1)
- Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Month 1(Baseline, Month 1)
- Change From Baseline in Bone Alkaline Phosphatase Levels at Month 1(Baseline, Month 1)
- Change From Baseline in Fasting Glucose Levels at Month 1(Baseline, Month 1)
研究者
研究点 (2)
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