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Idiopathic Short Stature (ISS)Phase 3NCT07815626

Phase 3 Study to Evaluate the Efficacy and Safety of Human Growth Hormone Injection (Sinotropin AQ) for the Treatment of Children With Idiopathic Short Stature

A Phase 3 study testing Human Growth Hormone (hGH) in people with Idiopathic Short Stature (ISS), run by Zhongshan Sansure Hygene Biomedicine Co., Ltd. at 34 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a multicenter, randomized, open-label, active-controlled, non-inferiority Phase III clinical trial. It aims to evaluate the efficacy and safety of Human Growth Hormone (hGH) Injection (Sinotropin AQ) in pediatric participants with Idiopathic Short Stature (ISS). Read more about this study

Who is it for?
Ages 3 to 11 years
Conditions the study is for
Idiopathic Short Stature (ISS)
What is being tested?
Human Growth Hormone (hGH)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
34 sitesChina
Study dates
Sep 2026to Feb 2029
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 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 1. Tanner stage I (prepubertal) at informed consent: males aged 3 to <11 years ; females aged 3 to <10 years ;
  • 2. At screening, height < -2 standard deviations (SD) for age and sex (height reference per Appendix 1);
  • 3. Peak GH ≥10.0 ng/mL in any growth hormone (GH) stimulation test;
  • 4. Bone age minus chronological age ≤ 1 year.

Who cannot join

  • 1.Closed epiphyses (skeletally mature)；
  • 2.Severe allergic diathesis, or known hypersensitivity to growth hormone or any of its excipients；
  • 3.History of malignancy or current active malignancy；
  • 4.Systemic chronic diseases, including but not limited to moderate-to-severe anemia, hypothyroidism, chronic kidney disease, cardiovascular disease (e.g., dilated cardiomyopathy), psychiatric disorders, or congenital anomalies that require clinical intervention per the investigator's judgment.
  • 5.Patients with a prior diagnosis of intracranial hypertension;
  • 6.Patients with congenital skeletal dysplasia, or scoliosis ≥15° (or moderate or greater), limping (gait disturbance), and patients with a prior diagnosis of slipped capital femoral epiphysis ;
  • 7.Other types of growth and developmental disorders, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, small for gestational age (SGA), short stature due to SHOX gene defects, and short stature of other identified causes;
  • 8. Patients with a confirmed diagnosis of diabetes mellitus, or fasting blood glucose ≥6.1 mmol/L on two consecutive measurements.

Trial locations and contacts

34 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jian Qi contact

+86 13581831286

jian.qi@sansure.com

34 sites in 1 country

China34 sites

  • Capital Center for Children's Health, Captical Medical University

    Beijing, Beijing Municipality

    Bingyan Cao

  • Changsha Hospital for Maternal and Child Health Care

    Changsha, Hunan

    Xiaoni Kuang, MD, PhD

  • Hunan Children's Hospital

    Changsha, Hunan

    Sha Zhao, MD, PhD

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Xingxing Zhang

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

    Qingnan He, MD, PhD

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan

    Xinran Cheng, MD, PhD

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan

    Fan Yang, MD, PhD

  • Guangdong Hospital for Materal and Child Health Care

    Guangzhou, Guangdong

    Shu Liu, MD, PhD

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Zhe Meng, MD, PhD

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Yanhong Li, MD, PhD

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Chunlin Wang, MD, PhD

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

    Qin Zhou, MD, PhD

  • Anhui Provincial Children's Hospital

    Hefei, Anhui

    Yuqing Chen, MD, PhD

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Deyun Liu, MD, PhD

  • Shandong Provincial Hospital

    Jinan, Shandong

    Yan Sun, MD, PhD

  • Kunming Children's Hospital

    Kunming, Yunnan

    Na Tao, MD, PhD

  • Jiangxi Provincial Children's Hospital

    Nanchang, Jiangxi

    Li Yang, MD, PhD

  • Children's Hospital of Nanjing Medical University

    Nanjing, Jiangsu

    Wei Gu, MD, PhD

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

    Lan Ling, MD, PhD

  • Women and Children's Hospital of Ningbo University

    Ningbo, Zhejiang

    Shuxia Ding, MD, PhD

  • Qingdao Women and Children's Hospital

    Qingdao, Shandong

    Tang Li, MD, PhD

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

    Wenli Lu, MD, PhD

  • Shanghai Children's Hospital

    Shanghai, Shanghai Municipality

    Shasha Zhou, MD, PhD

  • Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

    Juan Li, MD, PhD

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

    Lianshu Han, MD, PhD

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

    Na Wu, MD, PhD

  • Shanxi Children's Hospital

    Taiyuan, Shanxi

    Gaixiu Zhang, MD, PhD

  • Tangshan Maternal and Child Health Hospital

    Tangshan, Hebei

    Lanying Wang, MD, PhD

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

    Rongxiu Zheng, MD, PhD

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Xiao'ou Shan, MD, PhD

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei

    Xiaoping Luo, MD, PhD

    Wei Wu, MD, PhD

  • Wuhan Children's Hospital

    Wuhan, Hubei

    Hui Yao, MD, PhD

  • Wuxi Children's Hospital

    Wuxi, Jiangsu

    Lulian Xu, MD, PhD

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Qun Lian, MD, PhD

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open-Label, Active-Controlled, Non-Inferiority Phase 3 Study to Evaluate the Efficacy and Safety of Human Growth Hormone Injection (Sinotropin AQ) for the Treatment of Children With Idiopathic Short Stature (ISS)

This study is a multicenter, randomized, open-label, active-controlled, non-inferiority Phase III clinical trial. It aims to evaluate the efficacy and safety of Human Growth Hormone (hGH) Injection (Sinotropin AQ) in pediatric participants with Idiopathic Short Stature (ISS). Eligible participants will be randomized to receive either the study drug or an active comparator for 52 weeks. The primary efficacy endpoint is height velocity (HV, cm/year) over the treatment period. The study drug will be administered subcutaneously once daily at a dose of 0.15 IU/kg. The results of this trial will provide evidence on whether hGH Injection represents an effective and safe treatment option for improving height in children with ISS.

Being tested
Human Growth Hormone (hGH)
Keywords
Idiopathic Short Stature, ISS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human Growth Hormone (hGH)Drug

    This product is human growth hormone (hGH) injection (Sinotropin AQ). Usage and dosage: 0.15 IU/kg/day (0.05 mg/kg/day), once daily, administered by subcutaneous injection.

  • Human Growth Hormone (hGH)Drug

    This product is human growth hormone (hGH) injection. Usage and dosage: 0.15 IU/kg/day (0.05 mg/kg/day), once daily, administered by subcutaneous injection

Study groups in NCT07815626
Study groupRoleWhat they receive
Human growth hormone Injection（Investigational product）ExperimentalThis product is human growth hormone (hGH) injection (Sinotropin AQ). Usage and dosage: 0.15 IU/kg/day (0.05 mg/kg/day), once daily, administered by subcutaneous injection.
Receives: Drug: Human Growth Hormone (hGH)
human growth hormone（hGH） injection（reference product）Active comparatorThis product is human growth hormone (hGH) injection. Usage and dosage: 0.15 IU/kg/day (0.05 mg/kg/day), once daily, administered by subcutaneous injection.
Receives: Drug: Human Growth Hormone (hGH)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The value of Annual Height velocity

    The value of Annual Height velocity (HV, cm/year)

    Measured: At the end of 52 weeks of treatment

Secondary outcomes (6)

  1. The change of ΔHT SDS value

    The change from baseline in height SDS (ΔHT SDS)

    Measured: At all visit points from baseline to week 52

  2. The change of IGF-1 SDS value

    The change of insulin-like growth factor-1 standard deviation score value

    Measured: At all visit points from baseline to Week 52

  3. The change of height velocity value (ΔHV)

    The change from baseline in height velocity(ΔHV)

    Measured: At all visit points from baseline to Week 52

  4. The change of bone age relative to change of chronological age(ΔBA/ΔCA) value

    The change of bone age (BA) relative to the change in chronological age (CA) from basline to end of 52-week treatment

    Measured: At all visit points from basline to week 52

  5. The safety of human growth hormone injection

    Evaluate all TEAEs, SAEs, and clinically significant abnormalities in laboratory tests, vital signs, and physical examination.

    Measured: Baseline, Week 13, Week 26, Week 39, and Week 52

  6. Immunogenicity of Human Growth Hormone Injection

    Assessment of anti-GH and neutralizing antibody incidence

    Measured: At all visit points from baseline to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionOct 2028 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

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
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07815626
Sponsor's protocol ID
SXHJ-GH-002
Status last verified
Sep 2026
First submitted
2 Sep 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Human Growth Hormone (hGH) in people with Idiopathic Short Stature (ISS), run by Zhongshan Sansure Hygene Biomedicine Co., Ltd. at 34 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 4 inclusion and 8 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 11 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 34 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 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 Jian Qi (+86 13581831286, jian.qi@sansure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The value of Annual Height velocity (time frame: At the end of 52 weeks of treatment). 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 NCT07815626.

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 11 Sep 2026.

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