A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics

A Phase II, Multicenter, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Polyethylene Glycol Recombinant Human Growth Hormone Injection in Short Children Born Small for Gestational Age (SGA)

This study will take place at multiple sites and is divided into three phases:an initial 4-week getting-to-know-you phase,a 26-week main phase where participants receive medication,and a 4-week follow-up phase.Participants will be divided into three groups:two will receive different doses of PEG-rhGH Injection,and the third will receive hGH Injection.The goal is to determine which medication works best.

Study Overview

• Status: Recruiting
• Conditions: Short Stature Children Born Small for Gestational Age (SGA)
• Intervention / Treatment: Drug: PEG-rhGH Injection; Drug: hGH Injection

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiao Ping Luo; Phone Number: +8613387522645; Email: xpluo888@sina.com
• Study Contact Backup: Name: Ling Hou; Phone Number: +8613437131846; Email: houlingtj@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
      • Contact: Ling Hou; Phone Number: +8613437131846; Email: houlingtj@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Born full-term and "small-for-dates" - Born at 37-41 weeks (full-term). - Birth weight below the 10th percentile for that week of pregnancy and sex .
• At least 3 years old on the day the parent signs the consent form.
• Still prepubertal (Tanner stage I - no signs of puberty yet).
• Height at the first study visit is more than 2 standard deviations below the average for his or her age and sex.
• Bone age on X-ray is no more than 1 year ahead of real age.
• Never taken growth hormone, IGF-1, or any ghrelin-like medicine before.
• Both the subject and their guardian are able to voluntarily sign the Informed Consent Form (ICF) and voluntarily cooperate in completing the trial according to the protocol. If the subject is legally incompetent, written informed consent from their guardian shall be obtained. Additionally, relevant information about the clinical trial shall be communicated to the subject within their understanding, and the subject should be encouraged to sign the ICF personally as much as possible.

Exclusion Criteria:

• Severe allergy to growth hormone or its ingredients.
• Growth-hormone deficiency.
• Any chromosome/genetic/syndrome cause of short stature.
• Other diseases that can impair growth.
• Cognitive, developmental, or psychiatric disorders that could affect assessments .
• Current or past cancer, or high familial cancer risk.
• Positive hepatitis B, hepatitis C, HIV, or active tuberculosis at screening.
• Abnormal liver or kidney blood tests.
• Pre-diabetes or diabetes at screening .
• Systemic steroids > 28 consecutive days or > 14 days total in the last 3 months.
• High-dose inhaled steroids > 28 days in the last year.
• Prior use of aromatase inhibitors, GnRH analogues, sex hormones, anabolic agents, or other drugs that affect growth. 13. Unable to receive subcutaneous injections.
• Claustrophobia or inability to undergo brain MRI.
• Participated in another clinical trial with investigational treatment within 3 months.
• Any other condition that, in the investigator's opinion, makes the child unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEG-rhGH dose 1 weekly; Jintrolong® dose 1, subcutaneous injection, once every week for 26 weeks.	Drug: PEG-rhGH Injection; Jintrolong® Dose 1, subcutaneous injection, once weekly for 26 weeks for 24 subjects.. Jintrolong® Dose 2, subcutaneous injection, once weekly for 26 weeks for 24 subjects..; Other Names: Jintrolong®
Experimental: PEG-rhGH dose 2 weekly; Jintrolong® dose 2, subcutaneous injection, once every week for 26 weeks	Drug: PEG-rhGH Injection; Jintrolong® Dose 1, subcutaneous injection, once weekly for 26 weeks for 24 subjects.. Jintrolong® Dose 2, subcutaneous injection, once weekly for 26 weeks for 24 subjects..; Other Names: Jintrolong®
Active Comparator: Daily hGH (active control); Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks.	Drug: hGH Injection; Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks (active comparator) for 24 subjects.; Other Names: Jintropin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Annual height velocity at Week 26 of treatment	26 Weeks

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2025
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 3, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: polyethylene glycol-recombinant human growth hormone
• Other Study ID Numbers: GenSci031-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No