NCT04633057已完成3 期
A Phase III, Randomized, Open-label, Positive-controlled, Multi-center Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency
TJ Biopharma Co., Ltd.30 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2021年1月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 30
- 主要终点
- The Annualized Height velocity at 52 week
研究概览
简要总结
A Phase III, Randomized, open-label, positive-drug parallel control, Study to Evaluate the Efficacy and Safety of TJ101 in Child subject with growth hormone deficieney.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys: 3 years ≤ boy's age ≤ 10 years；Girls: 3 years ≤ girl's age ≤ 9 years
- •Pre-pubertal children(Tanner stage I)
- •GHD confirmed by 2 different GH provocation tests with peak GH concentration below 10 ng/mL in screening or one month
- •Height (HT) of at least 2.0 standard deviations (SD) below the mean height for chronological age (CA) and gender according to Table of standard deviation unit values of age and height of Chinese children aged 3-12 years , (HT SDS ≤ -2.0)
- •Height velocity≤5.0cm/years (Including height records before at least three months)；
- •IGF-1 SDS≤-1.0
- •Bone age (BA) is no more than two chronological age
- •Body mass Index (BMI) must be within ±2 SD of mean BMI for the chronological age and sex according to Table of standard deviation unit values of Age and BMI of Chinese children aged 3-12 years
- •Without prior exposure to any rhGH therapy
- •For children with growth hormone deficiency that is one of its multiple pituitary hormone deficiencies, alternative therapies targeting the hypothalamus-pituitary-target gland axis must be used for at least 3 months before screening
- •Written informed consent of the parent or legal guardian of the subject and assent of the subject (if the subject can read)
排除标准
- •beyond physiological dosage of glucocorticoid therapy
- •Evidence of closed epiphyses
- •Any other chronic condition that can cause short stature and cannot be treated with hormone replacement therapy(Including but not limited Chronic kidney disease, malnutrition, absorption disorders, uncontrolled hypothyroidism, celiac disease, rickets and social-psychological dwarfism)
- •Abnormal liver and renal function (ALT>1.5 times the upper limit of normal range and Cr exceeding the upper limit of normal range)
- •Presence of anti-hGH antibodies at screening
- •Concomitant administration of other treatments that may have an effect on growth such as anabolic steroids, with the exception of ADHD(attention deficit hyperactivity disorder) drug hormone replacement therapies [thyroxine, hydrocortisone, desmopressin (DDAVP)]
- •Mutations in growth hormone receptors are suspected, or any syndrome that causes insensitivity to growth hormone
- •At screening, ophthalmologic examination (including fundus microscopy) indicated increased intracranial pressure and/or retinopathy.
- •At screening, previous or existing intracranial tumor growth was confirmed by cranial magnetic resonance imaging (MRI) scan (using contrast agent) (MRI results up to 1 year prior to screening were acceptable)
- •Diseases such as severe cardiopulmonary, blood system, malignant tumor or potential tumor (family history), or systemic infection, low immune function and mental diseases
- •Significant spinal abnormalities, including scoliosis (Cobb Angle & GT;60 ˚), kyphosis and spina bifida.
- •Subjects diagnosed with type 2 or type 1 diabetes who were considered to have received no standard treatment, did not follow their prescribed treatment, or exhibited poor metabolic control, or had fasting glucose > 5.6 mmol/L twice in a row
- •Chromosomal abnormalities and medical syndromes (Turner's syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, SHOX mutations/deletions and skeletal dysplasias), with the exception of septo-optic dysplasia
- •Children with low birth weight (birth weight and/or body length are 2 SD below average according to the standard of the general Chinese population of the same gestational age and sex)
- •The subject and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct
- •Subject who has received an investigational product or has participated in a clinical study within 30 days before screening or during the clinical trials.
- •Known or suspected to be HIV positive, serologically positive for syphilis, or other chronic infectious diseases, such as AIDS, tuberculosis, hepatitis, etc
- •The history of drug, drug or alcohol abuse
- •Other conditions not considered suitable for inclusion by the researchers
研究组 & 干预措施
TJ101
Experimental
TJ101 1.2 mg/kg once a week for 52weeks
干预措施: TJ101 (Drug)
NordiFlex
Active Comparator
NordiFlex Injection 0.034 mg/kg once a day for 52 weeks
干预措施: NordiFlex (Drug)
结局指标
主要结局
The Annualized Height velocity at 52 week
时间窗: 52weeks after first dose
The Annualized Height velocity at 52 week
次要结局
- change in Annualized Height velocity at 26 week (compared to Baseline value)(26weeks after first dose)
- change in Annualized Height velocity at 52 week (compared to Baseline value)(52weeks after first dose)
研究者
研究点 (30)
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