Idiopathic Short Stature
Conditions
Interventions
Sponsors
Taizhou Hospital of Zhejiang Province
Eligibility
Sex/Gender
All
Age
4 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Age: >=4 years; 2. At screening, absolute height is below the 3rd percentile for normal children of the same age and sex; 3. Children prior to puberty (Tanner stage I) (refer to Appendix 1: Stages of Pubertal Development); 4. Patients currently receiving PEG-rhGH treatment with an initial dose of 0.22 mg/kg/w (initial dose defined as the first injection dose of PEG-rhGH administered); 5. Voluntary informed consent signed by the subject or their legal guardian.
Exclusion criteria
Exclusion criteria: 1. Individuals with known severe hypersensitivity or allergies to the investigational medicinal product or excipients used in this study; 2. Patients with confirmed malignancies or those at high risk of malignancy (based on a comprehensive assessment of tumour markers and other relevant information); 3. Confirmed diagnosis of other growth disorders, such as Turner syndrome, Noonan syndrome, Laron syndrome, growth hormone receptor deficiency, small for gestational age with short stature, growth retardation due to malnutrition, or growth retardation due to hypothyroidism; females with height below the mean height for age and sex minus 2.0 SDS who have not been excluded for chromosomal abnormalities; 4. Previous treatment with other formulations of recombinant human growth hormone; 5. Other circumstances deemed unsuitable for inclusion in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in height standard deviation score at one year of treatment;Bone maturation status; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in annual growth rate at one year of treatment; | — |
Countries
China
Contacts
Public ContactYao Huang
Taizhou Hospital of Zhejiang Province
Outcome results
None listed