Short Stature Children Born Small for Gestational Age (SGA)Phase 2NCT02375620
Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat SGA Children With Short Stature
A Phase 2 study testing PEG-somatropin in people with Short Stature Children Born Small for Gestational Age (SGA), run by Changchun GeneScience Pharmaceutical Co., Ltd. at 9 sites in China.
Trial summary
The study was evaluated as the optimal dose for the treatment of SGA short stature children by Pegylated Somatropin, initially evaluated its efficiency and safety for the treatment of SGA short stature children and provided scientific, reliable basis for phase III clinical trials for dose selection. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Short Stature Children Born Small for Gestational Age (SGA)
- What is being tested?
- PEG-somatropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 9 sitesChina
- Study dates
- 23 Apr 2015to Dec 2025
- 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 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The patients are diagnosed as being clinically full term small for gestational age infant.
- Girl are 3-6 years old, boys are 3-7 years old.
- Be in preadolescence (Tanner stage 1).
- The child did not achieve catch-up growth when he/she entered the group (the definition of catch-up growth is that the height is higher the third percentile with the same age and gender) (Appendix 2 and 3).
- The height of child is shorter than -2SDS of the median of normal children with the same age and gender when he/she entered the group (the mean height and height standard deviation of normal children with the same age and gender of normal children regard the height data in the physical development investigation data of children aged 0-18 in 9 cities of China (2005) as standard [13], Appendix 4 and 5).
- Within a year before entering the group, after any growth hormone stimulation test, the peak concentration of growth hormone in serum>10 µg/L.
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- Bone age≤ the actual age+1.
- The function of glucose regulation is normal: fasting blood glucose < 5.6mmol/L.
- Birth gestational age ≥ 37 weeks.
- The subjects and their guardians sign the informed consent (if the subjects is lack of ability for signing the informed consent, his legal guardian can write the subjects name instead).
- All experimental drug groups completed the main phase (52 weeks) of Phase II clinical trials, and the participants with complete follow-up records can enter the extension phase, provided that the continuous cessation of the use of pegylated recombinant human growth hormone injection lasts ≤ 8 weeks after the end of the first phase treatment and before the start of the extended study.
- Only when the subjects and their guardians are fully informed, express their willingness, and are able to cooperate in completing the treatment, follow-up, and various tests of the extension phase study, and have signed a written informed consent form, can they enter the extension phase trial.
Who cannot join
- People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal value, Cr> the upper limit of normal value).
- Patients are positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg).
- People with known highly allergic constitution or allergy to the drug or the excipient of the study.
- People with diabetes, severe cardiopulmonary, hematological system and malignant tumors diseases or general infection, immune deficiency and patients with mental disease.
- Other abnormal growth and development, such as Turner syndrome, Laron syndrome, growth hormone receptor deficiency.
- Potential tumor patients (family history).
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- Patients who used growth hormone for treatment.
- Subjects took part in other clinical trial study within 3 months.
- Patients used other hormonal for treatment within 3 months (such as sex hormone, glucocorticoid and etc., treat for more than a month) and received the drug treatment which may interfere with the secretion of GH or GH function (oxandrolone, growth hormone releasing hormone and etc.);
- Other conditions which in the opinion of the investigator preclude enrollment into the study.
- Subjects who have used the following medications within 2 months prior to entering the expansion phase of the trial:
- 1) Aromatase inhibitors (including but not limited to letrozole, anastrozole) used continuously for 1 month;
- 2) Gonadotropin-releasing hormone analogs (including but not limited to triptorelin, leuprolide, goserelin) used continuously for 1 month;
- 3) Sex hormones (including but not limited to any type of estrogen, progestin, and androgen) used continuously for 1 month;
- 4) Anabolic steroids (including but not limited to oxymetholone, danazol, stanozolol) used continuously for ≥ 1 month;
- 5) Oral or intravenous corticosteroids used for 1 month.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Children's Hospital, Capital Institute of Pediatrics
Beijing, Beijing Municipality
First Hospital of Jilin University
Changchun, Jilin
Hunan Children's Hospital
Changsha, Hunan
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Shanxi Children's Hospital/Shanxi Women and Children Hospital
Taiyuan, Shanxi
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu
About this study
Official title: A Multicenter, Randomized, Open-Label, Dose-Response, Phase II Clinical Study of Pegylated Somatropin (PEG Somatropin) Injection to Treat SGA Children With Short Stature.
The study was evaluated as the optimal dose for the treatment of SGA short stature children by Pegylated Somatropin, initially evaluated its efficiency and safety for the treatment of SGA short stature children and provided scientific, reliable basis for phase III clinical trials for dose selection.
This is a multicenter, randomized, open-label, dose-response trial, including a 52-week main phase and an ongoing safety extension phase continuing until reaching near-adult height (NAH) in China. Ninety-six growth hormone (GH)-treatment-naïve, non-GH-deficient, prepubertal short children born SGA were randomized in a 1:1 ration to receive weekly subcutaneous administration of Jintrolong 0.1 mg/kg/week or 0.2 mg/kg/week for 52 weeks. Children who completed the 52- week main phase proceeded to the extension phase, while Jintrolong was administered at an initial dose of 0.2 mg/kg/week. Dose adjustments based on annualized height velocity (AHV) and insulin-like growth factor I (IGF-I) response, were made up to a maximum of 0.4 mg/kg/week until achieved NAH or the patient's voluntary discontinuation.
- Being tested
- PEG-somatropin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-somatropinBiological
| Study group | Role | What they receive |
|---|---|---|
| PEG-somatropin: Low dose | Experimental | 0.1 mg/(kg.w), once per week for 52 weeks. Receives: Biological: PEG-somatropin |
| PEG-somatropin: High dose | Experimental | 0.2 mg/(kg.w), once per week for 52 weeks. Receives: Biological: PEG-somatropin |
| Children who completed the 52- week main phase proceeded to the extension phase | Experimental | Dose adjustments based on annualized height velocity (AHV; cm/year) and insulin-like growth factor I (IGF-I) response, were made up to a maximum of 0.4 mg/kg/week until achieved NAH or the patient's voluntary discontinuation. Receives: Biological: PEG-somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in height standard deviation scores (HT SDS) of the chronological age from baseline.
Measured: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
Secondary outcomes (6)
Annualized Height Velocity
Measured: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
The change of height from baseline
Measured: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
Bone maturity (bone age/ chronological age , △BA/△CA )
Measured: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
The change of IGF-1 standard deviation scores(IGF-1 SDS) from baseline
Measured: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
The change of mole ratio of IGF-1/IGFBP-3 from baseline
Measured: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
The change of BMI standard deviation scores(BMI SDS)
Measured: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study start23 Apr 2015
- Primary completion12 Dec 2023
- Study completionDec 2025 (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 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanxi Provincial Maternity and Children's Hospital, Children's Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The First Hospital of Jilin University, Hunan Children's Hospital, Tongji Hospital, Affiliated Hospital of Jiangnan University, Jiangxi Province Children's Hospital, Children's Hospital of The Capital Institute of Pediatrics
- Responsible party
- Sponsor
- Investigators
- Xiaoping Luo, Ph.D, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375620
- Sponsor's protocol ID
- GenSci 031 CT
- Status last verified
- May 2025
- First submitted
- 1 Feb 2015
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Dose-Response, Phase II Clinical Study of Pegylated Somatropin (PEG Somatropin) Injection to Treat SGA Children With Short Stature.
- ClinicalTrials.gov ID
- NCT02375620
- Acronym / sponsor ID
- GenSci 031 CT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanxi Provincial Maternity and Children's Hospital, Children's Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The First Hospital of Jilin University, Hunan Children's Hospital, Tongji Hospital, Affiliated Hospital of Jiangnan University, Jiangxi Province Children's Hospital, Children's Hospital of The Capital Institute of Pediatrics
- Study start
- 23 Apr 2015 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- 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.
The study was evaluated as the optimal dose for the treatment of SGA short stature children by Pegylated Somatropin, initially evaluated its efficiency and safety for the treatment of SGA short stature children and provided scientific, reliable basis for phase III clinical trials for dose selection.
This is a multicenter, randomized, open-label, dose-response trial, including a 52-week main phase and an ongoing safety extension phase continuing until reaching near-adult height (NAH) in China. Ninety-six growth hormone (GH)-treatment-naïve, non-GH-deficient, prepubertal short children born SGA were randomized in a 1:1 ration to receive weekly subcutaneous administration of Jintrolong 0.1 mg/kg/week or 0.2 mg/kg/week for 52 weeks. Children who completed the 52- week main phase proceeded to the extension phase, while Jintrolong was administered at an initial dose of 0.2 mg/kg/week. Dose adjustments based on annualized height velocity (AHV) and insulin-like growth factor I (IGF-I) response, were made up to a maximum of 0.4 mg/kg/week until achieved NAH or the patient's voluntary discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEG-somatropin: Low dose | Experimental | Biological: PEG-somatropin0.1 mg/(kg.w), once per week for 52 weeks. |
| PEG-somatropin: High dose | Experimental | Biological: PEG-somatropin0.2 mg/(kg.w), once per week for 52 weeks. |
| Children who completed the 52- week main phase proceeded to the extension phase | Experimental | Biological: PEG-somatropinDose adjustments based on annualized height velocity (AHV; cm/year) and insulin-like growth factor I (IGF-I) response, were made up to a maximum of 0.4 mg/kg/week until achieved NAH or the patient's voluntary discontinuation. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- The patients are diagnosed as being clinically full term small for gestational age infant.
- Girl are 3-6 years old, boys are 3-7 years old.
- Be in preadolescence (Tanner stage 1).
- The child did not achieve catch-up growth when he/she entered the group (the definition of catch-up growth is that the height is higher the third percentile with the same age and gender) (Appendix 2 and 3).
- The height of child is shorter than -2SDS of the median of normal children with the same age and gender when he/she entered the group (the mean height and height standard deviation of normal children with the same age and gender of normal children regard the height data in the physical development investigation data of children aged 0-18 in 9 cities of China (2005) as standard [13], Appendix 4 and 5).
Key exclusion criteria (16 listed)
- People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal value, Cr> the upper limit of normal value).
- Patients are positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg).
- People with known highly allergic constitution or allergy to the drug or the excipient of the study.
- People with diabetes, severe cardiopulmonary, hematological system and malignant tumors diseases or general infection, immune deficiency and patients with mental disease.
- Other abnormal growth and development, such as Turner syndrome, Laron syndrome, growth hormone receptor deficiency.
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-somatropin | Biological | Children who completed the 52- week main phase proceeded to the extension phase, PEG-somatropin: High dose, PEG-somatropin: Low dose |
Primary outcome
The change in height standard deviation scores (HT SDS) of the chronological age from baseline.
Time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
6 secondary outcomes
Annualized Height Velocity
Time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
The change of height from baseline
Time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
Bone maturity (bone age/ chronological age , △BA/△CA )
Time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
The change of IGF-1 standard deviation scores(IGF-1 SDS) from baseline
Time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
The change of mole ratio of IGF-1/IGFBP-3 from baseline
Time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
The change of BMI standard deviation scores(BMI SDS)
Time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.
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 May 2025.
- Derived from this study: 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. This study is not recruiting at the moment.
Xiaoping Luo, Ph.D principal investigator
Tongji Hospital
9 sites 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-somatropin in people with Short Stature Children Born Small for Gestational Age (SGA), run by Changchun GeneScience Pharmaceutical Co., Ltd. at 9 sites 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 12 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: under way, not looking for participants, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in height standard deviation scores (HT SDS) of the chronological age from baseline. (time frame: The main phase is at 52 weeks and the extension phase is at every 52 weeks up to study completion.). 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 NCT02375620, 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 May 2025.