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A real-world clinical study on the efficacy and compliance of polyethylene glycol recombinant human growth hormone injection in the treatment of patients with idiopathic short stature

A real-world clinical study on the efficacy and compliance of polyethylene glycol recombinant human growth hormone injection in the treatment of patients with idiopathic short stature

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085430
Enrollment
Unknown
Registered
2024-06-07
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic short stature

Interventions

trial group:NA

Sponsors

Huangshi Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1) Symmetric short stature. The height falls behind the 3rd percentile (P3, -1.88 SD) or 2 standard deviations (SD) of the growth curve of normal children of the same age and gender; 2) The results of any drug stimulation test indicate that the GH peak value is greater than 10ug/l; 3) Slow growth, growth rate<5cm/year; 4) Normal intelligence, mental state, and consciousness; 5) Birth length, weight, and body proportion are all normal, and no evidence of systemic, endocrine, nutritional, chromosomal abnormalities or genetic variations has been found; 6) After sufficient communication, the patient's family members were informed and agreed to use polyethylene glycol recombinant human growth hormone injection for treatment, and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Excluding other primary growth disorders that affect growth (such as genetic syndrome) and secondary growth disorders, including various diseases related to environment, hormones, nutrition, and/or systemic organic diseases, such as Cushing's syndrome, hypothyroidism, pseudohypoparathyroidism, growth hormone deficiency, bone/chondropathy, small for gestational age infants, chromosomal diseases, Turner syndrome, Noonan syndrome, etc; 2) Individuals who are allergic to polyethylene glycol recombinant human growth hormone injection (Jinsaizeng) and its excipients; 3) The patient has diseases and tumors that are not suitable for treatment with growth hormone, such as important organ dysfunction such as heart, liver, kidney, and other chronic diseases, or pituitary dysfunction, cerebrovascular diseases, etc; 4) Researchers believe that there are other situations where growth hormone therapy is not appropriate.

Design outcomes

Primary

MeasureTime frame
12 months after treatment, changes in height SDS and height SDS of subjects;12 months after treatment, the increase in height of the subjects;

Secondary

MeasureTime frame
Subject medication adherence during the study period;BMI and BMI SDS during the study period (3, 6, 9, and 12 months after treatment);Adverse drug reactions during the study period;Changes in height SDS and height SDS of subjects at 3, 6, and 9 months after treatment;After 3, 6, and 9 months of treatment, the increase in height of the subjects;

Countries

China

Contacts

Public ContactJianhua LIU

Huangshi Maternal and Child Health Hospital

18971785105@189.cn+86 189 7178 5105

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026