Short Stature Children Born Small for Gestational Age (SGA)Phase 2NCT07260500
A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics
A Phase 2 study testing PEG-rhGH Injection and hGH Injection in people with Short Stature Children Born Small for Gestational Age (SGA), run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Short Stature Children Born Small for Gestational Age (SGA)
- What is being tested?
- PEG-rhGH Injection and hGH Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2025to 30 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Ling Hou, +8613437131846, houlingtj@163.com
About this study
Official title: 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.
- Being tested
- PEG-rhGH Injection, hGH Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhGH InjectionDrug
Also called Jintrolong®
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..
hGH InjectionDrug
Also called Jintropin®
Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks (active comparator) for 24 subjects.
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhGH dose 1 weekly | Experimental | Jintrolong® dose 1, subcutaneous injection, once every week for 26 weeks. Receives: Drug: PEG-rhGH Injection |
| PEG-rhGH dose 2 weekly | Experimental | Jintrolong® dose 2, subcutaneous injection, once every week for 26 weeks Receives: Drug: PEG-rhGH Injection |
| Daily hGH (active control) | Active comparator | Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks. Receives: Drug: hGH Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual height velocity at Week 26 of treatment
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start11 Nov 2025
- Primary completion23 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Stature Children Born Small for Gestational Age (SGA)Studies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260500
- Sponsor's protocol ID
- GenSci031-202
- Status last verified
- Feb 2026
- First submitted
- 21 Nov 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07260500
- Acronym / sponsor ID
- GenSci031-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 23 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEG-rhGH dose 1 weekly | Experimental | Drug: PEG-rhGH InjectionJintrolong® dose 1, subcutaneous injection, once every week for 26 weeks. |
| PEG-rhGH dose 2 weekly | Experimental | Drug: PEG-rhGH InjectionJintrolong® dose 2, subcutaneous injection, once every week for 26 weeks |
| Daily hGH (active control) | Active comparator | Drug: hGH InjectionJintropin® dose 3, subcutaneous injection, once daily for 26 weeks. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-rhGH InjectionAlso: Jintrolong®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.. | Drug | PEG-rhGH dose 1 weekly, PEG-rhGH dose 2 weekly |
| hGH InjectionAlso: Jintropin®Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks (active comparator) for 24 subjects. | Drug | Daily hGH (active control) |
Primary outcome
Annual height velocity at Week 26 of treatment
Time frame: 26 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEG-rhGH Injection and hGH Injection in people with Short Stature Children Born Small for Gestational Age (SGA), run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao Ping Luo (+8613387522645, xpluo888@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual height velocity at Week 26 of treatment (time frame: 26 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.