A Phase III Clinical Study of Jinpei Growth Hormone Injection in the Treatment of Short Stature Children With Small for Gestational Age (SGA)

NCT07841678 | Not Yet Recruiting Phase 3

• 1 other identifier: GenSci031-301
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, open-label, active-controlled Phase III clinical study to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of once-weekly PEG-hGH injection compared with once-daily hGH injection in the treatment of prepubertal children with short stature due to small for gestational age (SGA) who have not received prior growth hormone treatment. Eligible subjects will be randomized in a 2:1 ratio to receive either PEG-hGH injection 0.3 mg/kg/week (experimental group) or hGH injection 0.066 mg/kg/day (active comparator group) for 52 weeks, followed by a 52-week extension period in which all subjects receive PEG-hGH injection 0.3 mg/kg/week. The primary endpoint is annualized height velocity (AHV) at Week 52.

Conditions

Small for Gestational Age

Outcome Measures

Primary Outcomes (1)

• Annualized Height Velocity (AHV)

  Week 52

Study Arms (2)

PEG-hGH Injection 0.3 mg/kg/week

EXPERIMENTAL

Subjects receive PEG-hGH injection at a dose of 0.3 mg/kg/week by subcutaneous injection, once weekly, for 52 weeks during the treatment period. In the extension period, all subjects continue to receive PEG-hGH injection 0.3 mg/kg/week for another 52 weeks.

Drug: PEG-hGH Injection

hGH Injection 0.066 mg/kg/day

ACTIVE COMPARATOR

Subjects receive hGH injection at a dose of 0.066 mg/kg/day by subcutaneous injection, once daily, for 52 weeks during the treatment period. In the extension period, subjects switch to PEG-hGH injection 0.3 mg/kg/week for 52 weeks.

Drug: hGH Injection

Interventions

PEG-hGH Injection DRUG

PEGylated recombinant human growth hormone (PEG-hGH) injection, trade name Jinsizeng. Dose: 0.3 mg/kg/week, subcutaneous injection, once weekly. Specification: 54 IU/9.0 mg/1.0 mL/vial. Administered via electronic pen injector.

PEG-hGH Injection 0.3 mg/kg/week

hGH Injection DRUG

Recombinant human growth hormone (hGH) injection, trade name Saizeng. Dose: 0.066 mg/kg/day, subcutaneous injection, once daily. Specification: 30 IU/10 mg/3 mL/vial. Administered via electronic pen injector.

hGH Injection 0.066 mg/kg/day

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of small for gestational age (SGA), with birth certificate or discharge record; gestational age ≥28 weeks; birth weight and/or length below the 10th percentile (P10) for sex and gestational age.
• Age ≥3 years at the time of informed consent (calculated from birth date on birth certificate/ID).
• Prepubertal boys and girls (Tanner stage I).
• Screening height \< -2 SD of normal height reference values for same sex and chronological age.
• Screening bone age \< chronological age + 1 year (bone age X-ray within 6 months before screening acceptable).
• No prior treatment with growth hormone, IGF-1, or insulin-like secretagogues.
• Subject and guardian able to voluntarily sign informed consent form (ICF) and comply with study procedures; for subjects without civil capacity, guardian's written informed consent required, with subject assent when possible.

You may not qualify if:

• Hypersensitivity to growth hormone class drugs or their excipients.
• Suspected or confirmed pediatric growth hormone deficiency (GHD) requiring GH stimulation testing (GH peak \>7 ng/mL excludes GHD).
• Known chromosomal or gene mutations affecting growth, or known syndromes including but not limited to GHD, Turner syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, Silver-Russell syndrome, skeletal dysplasia, SHOX gene abnormalities.
• Any known or suspected disease/condition that may cause short stature and may interfere with endpoint evaluation, including but not limited to chronic kidney disease, diabetes, skeletal dysplasia (with family history), severe spinal abnormalities, malnutrition, hypothyroidism, immunodeficiency.
• Current signs/symptoms of increased intracranial pressure, active proliferative retinopathy, or history of slipped capital femoral epiphysis or intracranial hypertension.
• Cognitive impairment, neurodevelopmental disorder or psychiatric illness that may interfere with endpoint evaluation.
• Current intracranial tumor, hematologic malignancy or other malignant tumor (regardless of treatment); family history of tumor or high tumor risk (e.g., Bloom syndrome, Fanconi syndrome, Down syndrome).
• Positive HBsAg at screening; history or diagnosis of hepatitis C, HIV infection or tuberculosis.
• Abnormal screening laboratory values considered by investigator to interfere with safety evaluation (ALT \>1.5×ULN; creatinine \>1.5×ULN).
• Screening indicates impaired fasting glucose, impaired glucose tolerance or diabetes.
• Systemic corticosteroid treatment within 3 months before screening (\>28 days cumulative or \>14 days continuous).
• Prior use of aromatase inhibitors, GnRH analogs, sex hormones, protein anabolic drugs, or other drugs affecting growth and development.
• Unable to receive subcutaneous injections (e.g., anticoagulant therapy, bleeding disorders, idiopathic thrombocytopenic purpura).
• Claustrophobia or inability to undergo head MRI.
• Participation in other clinical trials within 3 months before screening.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology.

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• Luo X, Hou L, Zhong Y, Zhao S, Chen X, Dong Q, Du H, Lu H, Yang Y, Wu X, Luo F, Chen R, Xu Z, Ma Y, Song W, Feng M, Gu X, Qiu W. A Phase 2 Study of PEGylated Recombinant Human Growth Hormone for 52 Weeks in Short Children Born Small for Gestational Age in China. Clin Endocrinol (Oxf). 2025 Feb;102(2):136-146. doi: 10.1111/cen.15156. Epub 2024 Nov 8.

  PMID: 39513569 RESULT

Central Study Contacts

Xiaoping Luo

CONTACT

+8613387522645; xpluo888@sina.com

Ling Hou

CONTACT

+8613437131846; houlingtj@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 25, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

CN (1)