EUCTR2016-000446-56-Outside-EU/EEA进行中（未招募）不适用
Clinical study to compare recombinant human growth hormone Cristalia(r-hGH Cristalia) versus Genotropin® in prepubertal children withgrowth deficiency due to deficiency of growth hormone. - CERES
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 94
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
- •Children aged 4 years and 13 years (for girls) and 14 years (for boys);
- •Children prepubertal (Tanner stage 1); Bone age less than 11 years (for
- •boys) and 9 years (for girls), documented by radiographs of the hand
- •and wrist (will accept a radiograph performed within 6 months prior to
- •enrollment in the study); Naïve children with growth hormone; Children
- •diagnosed with disturbance in growth due to deficiency of growth
- •hormone documented before initial treatment with r-hGH through: The
- •height z score <-2.0 SD for age and sex; A response to a test stimulus
- •GH release with peak blood 7 ng / ml in the presence of abnormalities
- •morphostructural hypothalamic-pituitary region shown by Nuclear
- •Magnetic Resonance (NMR) or; response to stimulus two tests of GH
- •release with peak 7 ng / ml in the presence of a normal NMR
- •(stimulating agents are acceptable insulin, clonidine, glucagon,
- •arginine and L-dopa). Historical values of GH in blood up to 12 months
- •prior to enrollment in the study will be acceptable. An MRI performed
- •up to 2 years before inclusion in the study is acceptable; History of
- •growth velocity below the mean for the normal population for at least 6
- •months prior to inclusion in the study, according to the table of VC
- •Tanner (must be historical height data with a minimum of 6 months
- •and maximum of 18 months. Researcher must ensure that the
- •measurements were performed in a standardized way in standard
- •stadiometer (rigid deck and rigid ruler); Baseline IGF-I -0.5 SD for age
- •and sex (results provided by the central laboratory).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 94
- •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
- •Children aged <4 years; Children with clinical signs of puberty (breast
- •/ genitalia and pubic hair Tanner stage 2); Note: Children who enterpuberty during treatment (breast development Tanner 2 / or testicles 4
- •ml or 2.5 cm in greatest diameter) shall be excluded; Other causes of
- •disorder in children including growth in stature for gestational age
- •(SGA), Turner syndrome, Prader-Willi syndrome, other causes; Children
- •with closed epiphyses bone; Children with physical changes that
- •prevent accurate measurement of height; Children with comorbidities
- •that prevent normal growth. Patients with central hypothyroidism may
- •be included, if well controlled with l-thyroxine, evidenced by normal
- •free T4 dosages; dysmorphic syndrome; Presence of signs of skeletal
- •dysplasia; Evidence of active malignancy or with less than two years of
- •treatment considered curative; uncontrolled growth of benign
- •intracranial tumors; Children with benign intracranial hypertension;
- •Children with clinical evidence of malnutrition considered relevant to
- •the discretion of the investigator; Children with Diabetes mellitus type
- •1 or 2; severe acute disease, including complications after heart
- •surgery by thoracotomy, abdominal surgery, multiple accidental trauma
- •or acute respiratory failure; concomitant chronic disease which may
- •interfere with the analysis of the study (eg, hyperthyroidism /
- •uncontrolled hypothyroidism, gastrointestinal diseases, cardiorespiratory
- •diseases, liver failure, kidney failure, bone pathologies that
- •can affect the growth, chronic inflammatory diseases and inborn errors
- •of metabolism); Patients with hormone deficiency related diseases by
- •panhypopituitarism may be included if properly controlled; MRI
- •findings that may interfere with the study drug (examples: intracranial
- •hypertension, tumors in the hypothalamic-pituitary region); Children
- •with anti-GH antibodies;
- •Children undergoing treatment for the disorder or attention deficit
- •hyperactivity disorder deficit hyperactivity disorder; Concomitant
- •medication that could influence the secretion of growth (eg, estrogen,
- •androgen, anabolic steroids, steroids, aromatase inhibitors) hormone.
- •Physiological doses of corticosteroids for the treatment of pituitary
- •deficiency are allowed as well as low-dose inhaled and / or nasal
- •steroids for the treatment of asthma or chronic rhinitis (500mcg or less
- •/ day beclomethasone or equivalent); or known allergy to the study
- •medications, or any of the excipients or thinner / solvent
- •hypersensitivity; Participation in another clinical study within 3 months
- •before study entry; Statement of legal limitation disability or parent /
- •legal representative
研究者
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