EUCTR2013-004468-69-GR进行中（未招募）1 期
A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren
Teva Pharmaceutical Industries, Ltd.0 个研究点目标入组 60 人开始时间: 2014年6月16日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •a. Pre-pubertal (Tanner 1/1/1) boys = 3 years to = 11 years and pre-pubertal girls = 3 years to = 10
- •years at time of informed consent signing with isolated idiopathic growth hormone (GH)
- •insufficiency, GH insufficiency as part of multiple pituitary hormone deficiencies, or organic GHinsufficiency (e.g., due to pituitary tumor, pituitary or brain surgery, intracranial radiation
- •b. Diagnosis confirmed by 2 different GH provocation tests for GH secretion (e.g., insulin tolerance
- •test and arginine test) as described in consensus guidelines (GH Research Society 2000, Gharib et
- •al 2003, Rose 2007). Historical medical documents of GH provocation tests [including the insulin
- •tolerance test (ITT) and arginine test; cortisol levels measured at 0 and 90 minutes during the ITT
- •test] can be used for study eligibility. The peak GH concentration must be below 10 ng/mL for
- •inclusion in the study;
- •c. All patients must have at least one cranial imaging study [magnetic resonance imaging (MRI) or
- •computed tomography (CT)] prior to randomization:
- •? To exclude intracranial causes of GHD in patients without a history of pituitary tumor
- •[obtained within 6 months prior to informed consent signing (Visit 1-SCR)], or
- •? Patients with a previously treated pituitary tumor must have no tumor progression for at
- •least the past year [obtained within 3 months prior to informed consent signing (Visit 1),
- •compared with a previous MRI or CT performed at least 12 months earlier].
- •If not performed within these specified time frames prior to informed consent signing, may be
- •performed as part of the screening procedures.
- •d. H-SDS = -2.0; using CDC 2000 growth reference standards (Kuczmarski et al, 2002) e. HV-SDS <0 (minimum time between 2 standard height measurements should be at least 6 months
- •prior to study entry; one of the measurements can be taken during the screening visit. The data
- •should be determined from medical records and include dates and method of height
- •measurement); using Swiss growth reference standards (Prader et al, 1989).
- •f. IGF-I SDS < -1.0;
- •g. Body Mass Index (BMI) =95th percentile of BMI for CA and sex according to the 2000 Centers
- •for Disease Control (CDC) standards;
- •h. Written Informed Consent of the parent(s) or legal guardian of the patient and a verbal or written
- •assent from the patients, where possible;
- •i. Parent or legal guardian who is capable and willing to administer the study drug.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •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
- •a. Any clinically significant abnormality as determined by the investigator, that is likely to affect
- •growth or ability to grow (e.g., chronic diseases such as renal insufficiency or advanced diseases
- •such as acquired immunodeficiency syndrome [AIDS] or tuberculosis; intracranial, cranio-spinal,
- •or spinal cord irradiation; malnutrition);
- •b. Contraindications to rhGH treatment;
- •c. History of or currently active malignancy, including malignant intra-cranial tumors;
- •d. Children with new diagnosis of pituitary/hypothalamic tumor or of intracranial tumor as
- •confirmed by MRI or CT within 12 months prior to baseline (Visit 2-BL);e. Bone age, determined by the standard method (Greulich and Pyle, 1959), greater than CA or
- •greater than 9 for girls or greater than 10 for boys within 3 months of screening. If not done
- •within 3 months of screening, may be performed as part of screening procedures;
- •f. Patients with known diagnosis of diabetes or pre-diabetes (impaired fasting glucose) as defined in
- •the American Diabetes Association position statement (American Diabetes Association, 2013);
- •g. Clinically-determined chromosomal abnormalities and medical syndromes” (e.g., Noonan
- •syndrome, Turner’s syndrome, Prader-Willi syndrome, Russell-Silver syndrome, short stature
- •homeobox [SHOX], mutations/deletions); Chromosomal testing may be ordered at the PI’s
- •discretion if needed.
- •h. Skeletal dysplasias;
- •i. Children born small for gestational age (SGA, defined as birth weight and/or birth length < -2
- •standard deviations [SDs] for gestational age);
- •j. Evidence of closed epiphyses;
- •k. Growth altering medications such as anabolic steroids or methylphenidate, except for pituitary
- •replacement hormone therapy (thyroxine, hydrocortisone, desmopressin);
- •l. Children requiring glucocorticoid therapy (e.g., for asthma) in excess of 400 µg/day of inhaled
- •budesonide (or equivalents) inhaled for longer than 1 month during the last calendar year;m. Poorly controlled or uncontrolled pituitary hormone insufficiencies (i.e., stable therapy less than 6
- •months for thyroid replacement and 3 months for other hormone replacements);
- •n. Hypersensitivity to the study medication components;
- •o. Participation in another investigational agent trial within 30 days prior to screening;
- •p. Other causes of short stature, such as celiac disease, malabsorption syndromes, untreated
- •hypothyroidism, rickets, psychosocial dwarfism;
- •q. Any medical condition as judged by the investigator to interfere with patient participation or the
- •objectives of the study;
- •r. Patients with signs and/or symptoms of increased intracranial pressure at screening.
研究者
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