Small for Gestational AgePhase 3NCT07841678
A Phase III Clinical Study of Jinpei Growth Hormone Injection in the Treatment of Short Stature Children With Small for Gestational Age (SGA)
A Phase 3 study testing PEG-hGH Injection and hGH Injection in people with Small for Gestational Age, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Small for Gestational Age
- What is being tested?
- PEG-hGH Injection and hGH Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Jan 2030
- Phase
- Phase 3
- 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
- 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.
Who cannot join
- 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.
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- 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.
- Other conditions considered by investigator unsuitable for enrollmen.
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
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology.
Wuhan, Hubei, 430030
About this study
Official title: A Multicenter, Randomized, Open-Label, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of Jinpei Growth Hormone Injection in the Treatment of Short Stature Children With Small for Gestational Age (SGA)
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
- Being tested
- PEG-hGH Injection, hGH Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-hGH InjectionDrug
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.
hGH InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: hGH Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Height Velocity (AHV)
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small for Gestational AgeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 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
- NCT07841678
- Sponsor's protocol ID
- GenSci031-301
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39513569
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of Jinpei Growth Hormone Injection in the Treatment of Short Stature Children With Small for Gestational Age (SGA)
- ClinicalTrials.gov ID
- NCT07841678
- Acronym / sponsor ID
- GenSci031-301
- Conditions
- Small for Gestational Age
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 25 Sep 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-hGH Injection 0.3 mg/kg/week | Experimental | Drug: PEG-hGH InjectionSubjects 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. |
| hGH Injection 0.066 mg/kg/day | Active comparator | Drug: hGH InjectionSubjects 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. |
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)
- 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).
Key exclusion criteria (16 listed)
- 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.
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-hGH InjectionPEGylated 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. | Drug | PEG-hGH Injection 0.3 mg/kg/week |
| hGH InjectionRecombinant 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. | Drug | hGH Injection 0.066 mg/kg/day |
Primary outcome
Annualized Height Velocity (AHV)
Time frame: Week 52
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 25 Sep 2026.
- Results publication: PubMed 39513569Luo 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.
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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 3 study testing PEG-hGH Injection and hGH Injection in people with Small for Gestational Age, 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 16 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: opening soon, as of the sponsor's last update on 25 Sep 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xiaoping 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?
Annualized Height Velocity (AHV) (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07841678, which also lists 1 linked publication.
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 25 Sep 2026.