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Evaluating the dose-response correlation of PEG-rhGH in the treatment of short stature children

Evaluating the dose-response correlation of PEG-rhGH in the treatment of short stature children

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097861
Enrollment
Unknown
Registered
2025-02-26
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

GHD, ISS

Interventions

0.2mg/kg/w PEG-rhGH:None
0.2mg/kg/w - 0.22mg/kg/w PEG-rhGH:None
>0.22mg/kg/w PEG-rhGH:None

Sponsors

Suzhou Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1.4-14 years old; 2.Conforming to the diagnostic criteria of GHD or ISS; 3.Treated or intend to treat with PEG-rhGH;

Exclusion criteria

Exclusion criteria: 1.Epiphyseal closure; 2.Patient with skeletal growth and development disorders, genetic metabolic conditions, severe cardiopulmonary, hematological, and malignant neoplasms, as well as systemic infections, immunodeficiencies, and mental health disturbances; 3.Significant familial short stature (the hight of father < 155 cm or the hight of mother < 145 cm); 4.Simultaneous administration of additional drugs potentially impacting efficacy over a month duration, such as other GH treatments, anti-estrogens, GnRHa, endocrine sex steroids, anabolic-androgenic steroids, somatostatin and somatostatin analogues, excessive glucocorticoid doses, parathyroid hormone inhibitors, etc; 5.Those who have received any other growth hormone therapy other than the study drug within 6 months before screening, or who have stopped taking the drug for more than 2 months during the course of treatment; 6.Not provide complete medical records; 7.Any other condition that the investigator considers inappropriate for inclusion in the study;

Design outcomes

Primary

MeasureTime frame
Ht,GV;

Secondary

MeasureTime frame
IGF-1;Biochemical indicators;body compositon, Bone age, bone mineral density;

Countries

China

Contacts

Public Contactkan ye

Suzhou Municipal Hospital

yekan001@163.com+86 512 62367718

Outcome results

None listed

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