Idiopathic short stature
Conditions
Interventions
Treatment group:None
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
4 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Provide an informed consent signed and dated by the study participant/legal guardian; 2. ISS children treated with PEGylated recombinant human growth hormone; 3. The height of the child was at or below the 3rd percentile or -2SDS of the height of a healthy child of the same age and sex before starting PEGylated recombinant human growth hormone therapy; 4. Age >= 4 years before starting PEGylated recombinant human growth hormone therapy; 5. Preadolescent (Tanner I stage and before) before starting PEGylated recombinant human growth hormone therapy; 6. No history of growth hormone therapy.
Exclusion criteria
Exclusion criteria: 1. Birth weight below P10 for children of the same age, sex and gestational age; 2. Known allergy to PEG rhGH or excipients; 3. Children with nutritional problems or chromosomal abnormalities; 4. Abnormal liver and kidney function (ALT > 1.5 times the upper limit of normal, Cr > the upper limit of normal); 5. Patients with endocrine systemic diseases, serious cardiopulmonary and blood system diseases, or systemic active infections, immunocompromised patients and psychiatric patients; 6. Patients who have had or currently have tumors, or who are undergoing screening for potential tumors (family history); 7. Other types of growth and development abnormalities, such as Turner syndrome, Laron syndrome, growth hormone receptor deficiency, etc.; 8. Have participated in other drug clinical trials within 3 months; 9. Other conditions deemed unsuitable for inclusion in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?HtSDS after 52 weeks of use; | — |
Secondary
| Measure | Time frame |
|---|---|
| ?HV(52weeks);PedsQL;?IGF-1 ??IGF-/IGFBP-3(52weeks);?IGF-1 ??IGF-/IGFBP-3(104weeks); | — |
Countries
China
Contacts
Public ContactLing Hou
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed