ISS
Conditions
Interventions
Experimental group with a dose of 0.3mg:0.3mg/kg/week Jintrolong?
Experimental group with a dose of 0.2mg:0.2mg/kg/week Jintrolong?
0.25mg:0.25mg/kg/week Jintrolong?
Sponsors
Children's Hospital,Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
5 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. Age: Girls from 5 to 10 years old, boys from 5 to 11 years old; 2. At the screening period, the height should be below -2SD (standard deviation) of the normal height for children of the same chronological age and gender; 3. Prepubertal children (Tanner Stage I); 4. Within 1 year prior to screening, the peak serum growth hormone concentration during any growth hormone stimulation test should be >=10 µg/L (ng/ml); 5. At the time of screening, the bone age (BA) should be <= the chronological age; 6. No previous growth hormone treatments, including but not limited to growth hormone, insulin-like growth factor, sex hormones, and aromatase inhibitors; 7. The participant and the guardian are willing and able to cooperate with the completion of scheduled visits, treatment plans, laboratory tests, and other trial procedures. The guardian or the participant themselves voluntarily signs the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to the study intervention product or related products; 2. Subjects with hepatic dysfunction or renal dysfunction (ALT > upper limit of normal; Cr > upper limit of normal); 3. A history of hepatitis B or C, or known active hepatitis B or C (this exclusion criterion does not include the presence of antibodies due to hepatitis B vaccination); 4. Current or previously diagnosed patients with malignant tumors; or patients judged by the investigator to have a high risk of cancer (such as having two or more relatives within three generations with the same type of cancer); 5. Confirmed diagnosis of other types of growth and developmental abnormalities, such as Turner syndrome, Noonan syndrome, Laron syndrome, growth hormone receptor deficiency, small for gestational age with short stature, growth retardation due to malnutrition, hypothyroidism-induced growth retardation, etc. Female patients with a height =15 degrees, or moderate to severe scoliosis requiring treatment), or claudication; 7. Diagnosed with diabetes, or at the time of screening, laboratory tests/screening reveal a fasting blood glucose >= 126 mg/dL (7.0 mmol/L) or glycated hemoglobin (HbA1c) >= 6.5%; 8. Children who are concurrently using other treatments that may affect growth, such as but not limited to the use of methylphenidate for the treatment of attention deficit hyperactivity disorder (ADHD), systemic corticosteroid therapy for more than 2 consecutive weeks within 3 months prior to screening for current inflammatory diseases, or inhaled budesonide at a dose greater than 400 µg/day or equivalent doses of inhaled glucocorticoids for more than 4 consecutive weeks within 12 months prior to screening; 9. Children with hypothyroidism and/or adrenal insufficiency who have not received adequate and stable replacement therapy for at least 90 days prior to randomization; 10. Participation in any other clinical trial within 3 months prior to screening and having received drug or non-drug interventions; 11. Other conditions deemed inappropriate for inclusion in this clinical trial by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?Ht SDS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose, fasting insulin, thyroid function,IGF-1;?HV;Blood routine test, urine routine test, liver and kidney function test, calcium and phosphorus?OGTT-2H,OGTT-2Htest, lipid and glycated hemoglobin test, bone age X-ray examination, full spine anteroposterior and lateral X-ray examination; | — |
Countries
China
Contacts
Public ContactFu Junfen
Children's Hospital,Zhejiang University School of Medicine
Outcome results
None listed