A phase IV open-label study of predictive markers in Growth Hormone Deficient and Turner Syndrome prepubertal children treated with Saizen

Merck Serono International S.A.0 个研究点目标入组 326 人2005年6月7日

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: - growth failure in children caused by decreased or absent secretion of endogenous growth hormone.- growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis.
发起方: Merck Serono International S.A.
入组人数: 326
状态: 进行中（未招募）
最后更新: 12年前

暂无简介。

注册库

who.int

开始日期

2005年6月7日

结束日期

待定

最后更新

12年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Merck Serono International S.A.

•\- Children with one of the following diagnoses who are candidate for Saizen therapy:
•A) GHD: documented pre\-established diagnosis of GHD with a GH peak response of \<10 micrograms/L with 2 GH stimulation tests, without priming with oestradiol
•B) Turner syndrome: documented pre\-established diagnosis by karyotype
•\- Prepubertal status according to Tanner (stage 1\)
•\- Pre\-established history of normal tyroid 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 trial
•\- Parent's or guardian's written informed consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care. If the child is old enough to read and write, a separate form will be given
•Are the trial subjects under 18? yes
•Number of subjects for this age range:

•\- Acquired GHD due to central nervous system tumour, trauma, infection, infiltration (documented by imaging), and a history of irradiation or cranial surgery;
•\- Previous treatment with GH, GHRH, anabolic steroids or any treatment affecting growth;
•\- Previous treatment with corticosteroids except topical or inhaled for atopic disease; or when used for hormonal substitution if the condition and treatment regimen has been stable for at least 3 months;
•\- Severe associated pathology affecting growth such as malnutrition, malabsorption or bone dysplasia;
•\- Chronic severe kidney or liver or infectious disease;
•\- Acute or severe illness during the previous 6 months;
•\- 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;
•\- Diabetes Mellitus type I and II
•\- Any autoimmune disease (except chronic auto\-immune thyroiditis with normal levels of thyroid hormones);