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Clinical study of growth hormone in the treatment of short stature children in late adolescence

Clinical study of growth hormone in the treatment of short stature children in late adolescence

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043880
Enrollment
Unknown
Registered
2021-03-04
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-07-05

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

Conditions

short stature

Interventions

Sponsors

The First Affiliated Hospital of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Bone age >=14 years in boys and 13 years in girls; (2) Height less than or equal to -2.0SDS compared to same sex and age; (3) Growth velocity = 10th percentile of the same sex and gestational age; (7) The thyroid function is normal, including blood free thyroxine (FT4), free triiodothyronine (FT3) and thyroid-stimulating hormone (TSH) levels within the normal reference value range; (8) The karyotype of the chromosome is normal, 46,XX (only female whose height iless than or equal to -2.0SDS compared to same sex and age); (9) Patients who have not received rhGH treatment, GnRHa, aromatase analogs and other drugs in the past 2 years; (10) Children with no contraindications to rhGH treatment evaluated by a doctor;=

Exclusion criteria

Exclusion criteria: (1) Patients with liver and kidney dysfunction (ALT>2 times the upper limit of normal value, Cr>upper limit of normal value); (2) Patients with active hepatitis B; (3) Patients with severe heart and lung, blood system, malignant tumors, diabetes and other diseases or systemic infections, and immunocompromised patients; (4) Diagnosed with other types of growth and development abnormalities, such as growth hormone deficiency, polypituitary hormone deficiency, Turner syndrome, Noonan syndrome, Laron syndrome, growth hormone receptor deficiency, small for gestational age with short stature, Growth retardation caused by malnutrition, growth retardation caused by hypothyroidism, etc., girls with lagging growth did not rule out chromosomal abnormalities; (5) Children with microcephaly or with intelligence or developmental retardation or with abnormal skeletal development or with other congenital malformations; (6) Growth rate <0.5cm in the past 3 months; (7) Those who are known to be highly allergic or allergic to the test drug in this study; (8) Participants in clinical trials of other drugs related to growth and development within 3 months; (9) The investigator believes that the patient is not suitable for other situations in this study.

Design outcomes

Primary

MeasureTime frame
height;CV;PAH;HtSDSBA;bone age;knee score;

Countries

China

Contacts

Public ContactWang Chun-Lin

The First Affiliated Hospital of Zhejiang University

hzwangcl@zju.edu.cn+86 571-87233418

Outcome results

None listed

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