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)
1 other identifier
interventional
72
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2025
CompletedFirst Submitted
Initial submission to the registry
November 21, 2025
CompletedFirst Posted
Study publicly available on registry
December 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
February 17, 2026
February 1, 2026
1.1 years
November 21, 2025
February 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Annual height velocity at Week 26 of treatment
26 Weeks
Study Arms (3)
PEG-rhGH dose 1 weekly
EXPERIMENTALJintrolong® dose 1, subcutaneous injection, once every week for 26 weeks.
PEG-rhGH dose 2 weekly
EXPERIMENTALJintrolong® dose 2, subcutaneous injection, once every week for 26 weeks
Daily hGH (active control)
ACTIVE COMPARATORJintropin® dose 3, subcutaneous injection, once daily for 26 weeks.
Interventions
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..
Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks (active comparator) for 24 subjects.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2025
First Posted
December 3, 2025
Study Start
November 11, 2025
Primary Completion (Estimated)
December 23, 2026
Study Completion (Estimated)
April 30, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02