A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency

Exclusion Criteria

• •1. beyond physiological dosage of glucocorticoid therapy
• •2. Evidence of closed epiphyses
• •3. 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)
• •4. Abnormal liver and renal function (ALT\>1.5 times the upper limit of normal range and Cr exceeding the upper limit of normal range)
• •5. Presence of anti-hGH antibodies at screening
• •6. 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 \[thyroxine, hydrocortisone, desmopressin (DDAVP)\]
• •7. Mutations in growth hormone receptors are suspected, or any syndrome that causes insensitivity to growth hormone
• •8. At screening, ophthalmologic examination (including fundus microscopy) indicated increased intracranial pressure and/or retinopathy.
• •9. 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)
• •10. Diseases such as severe cardiopulmonary, blood system, malignant tumor or potential tumor (family history), or systemic infection, low immune function and mental diseases
• •11. Significant spinal abnormalities, including scoliosis (Cobb Angle \& GT;60 ˚), kyphosis and spina bifida.
• •12. 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
• •13. 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
• •14. 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)
• •15. The subject and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct
• •16. Subject who has received an investigational product or has participated in a clinical study within 30 days before screening or during the clinical trials.
• •17. Known or suspected to be HIV positive, serologically positive for syphilis, or other chronic infectious diseases, such as AIDS, tuberculosis, hepatitis, etc
• •18. The history of drug, drug or alcohol abuse
• •19. Other conditions not considered suitable for inclusion by the researchers