Growth Hormone TreatmentNCT06037473
The Efficacy and Safety of PEGylated GH for the Treatment of Short Stature in Chinese Children-GLOBE Reg
An observational study of Growth Hormone Treatment and Growth Disorders, run by Beijing Children's Hospital at 1 site in China.
Trial summary
In order to further observe the long-term safety and effectiveness of real-world polyethylene glycol-recombinant human growth hormone(PEG-rhGH) treatment of GHD, idiopathic short stature, and SGA in children, explore and analyze the factors affecting the efficacy of PEG-rhGH and the height prediction model after… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Growth Hormone Treatment, Growth Disorders
- What is being tested?
- Polyethylene glycol recombinant human growth hormone injection
- Type of treatment
- Injection or infusion
- How many people
- 2,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Aug 2029
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The height of the patients was below 2 stadard deviation below average. The patients were diagosesed as endogenous growth hormone deficiency, TS, SGA, ISS, etc. and treated with polyethylene glycol recombinant human growth hormone injection
Who may be able to join
- Patients with endogenous growth hormone deficiency, Turner Syndrome, SGA, idiopathic short stature, etc. treated with polyethylene glycol recombinant human growth hormone injection
Who cannot join
- Patients with serious heart and lung, blood system, malignant tumors and other diseases or systemic infections, immune function is low and Persons with mental illness;
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
Department of Endocrinology, Genetics, Metabolism
Beijing, Beijing Municipality, 010
chunxiu Gong, doctor, 13370115001 ext. 59616326, chunxiugong@163.com
About this study
Official title: A Real-world Study of the Efficacy and Safety of PEGylated Recombinant Human Growth Hormone Injection in the Treatment of Short Stature in Chinese Children From the Global Registry for Novel Therapies For Rare Bone or Endocrine Conditions
In order to further observe the long-term safety and effectiveness of real-world polyethylene glycol-recombinant human growth hormone(PEG-rhGH) treatment of GHD, idiopathic short stature, and SGA in children, explore and analyze the factors affecting the efficacy of PEG-rhGH and the height prediction model after treatment, etc., collect and analyze more scientifically and rationally, and understand the situation of real-world PEG-GH treatment. A database registration study was developed.
Read the detailed description
A database registration study was developed to retrospectively analyze the efficacy and safety of polyethylene glycol recombinant human growth hormone injection in the treatment of slow growth in children caused by endogenous growth hormone deficiency, idiopathic short stature, Turner syndrome, etc., and to further prospectively follow up and monitor. In order to participate in the global real-world use of long-acting growth hormone, all data from this study were uploaded to the Global Registry of New Therapies for Rare Endocrine Diseases and Bone Disorders (GloBE-Reg) platform.
- Conditions
- Growth Hormone Treatment, Growth Disorders
- Being tested
- Polyethylene glycol recombinant human growth hormone injection
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycol recombinant human growth hormone injectionDrug
0.1-0.3mg/kg.w
| Study group | Role | What they receive |
|---|---|---|
| growth hormone deficiency(GHD) | Growth hormone deficiency (GHD) is a rare and treatable condition that causes short height in children and metabolic issues in adults. Receives: Drug: Polyethylene glycol recombinant human growth hormone injection | |
| Idiopathic short stature (ISS) | Idiopathic short stature is a condition in which the height of the individual is more than 2 SD below the corresponding mean height for a given age, sex and population, in whom no identifiable disorder is present. Receives: Drug: Polyethylene glycol recombinant human growth hormone injection | |
| small for gestational age (SGA) | Small for gestational age (SGA) is defined as a birth weight of less than 10th percentile for gestational age. Receives: Drug: Polyethylene glycol recombinant human growth hormone injection | |
| Turner Syndrome (TS) | Turner syndrome, a condition that affects only females, results when one of the X chromosomes (sex chromosomes) is missing or partially missing. Receives: Drug: Polyethylene glycol recombinant human growth hormone injection | |
| others | others who with the height of the individual is more than 2 SD below the corresponding mean height for a given age, sex and population. Receives: Drug: Polyethylene glycol recombinant human growth hormone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in height standard deviation score
final adult height standard deviation score- height standard deviation score before treatment
Measured: 3-10years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Aug 2023
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone TreatmentStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Principal investigator, Chunxiu Gong, Beijing Children's Hospital
- Investigators
- Bingyan Cao, Dr., Principal investigator, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037473
- Sponsor's protocol ID
- Gensci-LAGH-23003
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of the Efficacy and Safety of PEGylated Recombinant Human Growth Hormone Injection in the Treatment of Short Stature in Chinese Children From the Global Registry for Novel Therapies For Rare Bone or Endocrine Conditions
- ClinicalTrials.gov ID
- NCT06037473
- Acronym / sponsor ID
- Gensci-LAGH-23003
- Conditions
- Growth Hormone Treatment, Growth Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 14 Sep 2023 (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.
In order to further observe the long-term safety and effectiveness of real-world polyethylene glycol-recombinant human growth hormone(PEG-rhGH) treatment of GHD, idiopathic short stature, and SGA in children, explore and analyze the factors affecting the efficacy of PEG-rhGH and the height prediction model after treatment, etc., collect and analyze more scientifically and rationally, and understand the situation of real-world PEG-GH treatment. A database registration study was developed.
Detailed description
A database registration study was developed to retrospectively analyze the efficacy and safety of polyethylene glycol recombinant human growth hormone injection in the treatment of slow growth in children caused by endogenous growth hormone deficiency, idiopathic short stature, Turner syndrome, etc., and to further prospectively follow up and monitor. In order to participate in the global real-world use of long-acting growth hormone, all data from this study were uploaded to the Global Registry of New Therapies for Rare Endocrine Diseases and Bone Disorders (GloBE-Reg) platform.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| growth hormone deficiency(GHD) | – | Drug: Polyethylene glycol recombinant human growth hormone injectionGrowth hormone deficiency (GHD) is a rare and treatable condition that causes short height in children and metabolic issues in adults. |
| Idiopathic short stature (ISS) | – | Drug: Polyethylene glycol recombinant human growth hormone injectionIdiopathic short stature is a condition in which the height of the individual is more than 2 SD below the corresponding mean height for a given age, sex and population, in whom no identifiable disorder is present. |
| small for gestational age (SGA) | – | Drug: Polyethylene glycol recombinant human growth hormone injectionSmall for gestational age (SGA) is defined as a birth weight of less than 10th percentile for gestational age. |
| Turner Syndrome (TS) | – | Drug: Polyethylene glycol recombinant human growth hormone injectionTurner syndrome, a condition that affects only females, results when one of the X chromosomes (sex chromosomes) is missing or partially missing. |
| others | – | Drug: Polyethylene glycol recombinant human growth hormone injectionothers who with the height of the individual is more than 2 SD below the corresponding mean height for a given age, sex and population. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The height of the patients was below 2 stadard deviation below average. The patients were diagosesed as endogenous growth hormone deficiency, TS, SGA, ISS, etc. and treated with polyethylene glycol recombinant human growth hormone injection
Key inclusion criteria (1 listed)
- Patients with endogenous growth hormone deficiency, Turner Syndrome, SGA, idiopathic short stature, etc. treated with polyethylene glycol recombinant human growth hormone injection
Key exclusion criteria (1 listed)
- Patients with serious heart and lung, blood system, malignant tumors and other diseases or systemic infections, immune function is low and Persons with mental illness;
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 |
|---|---|---|
| Polyethylene glycol recombinant human growth hormone injection0.1-0.3mg/kg.w | Drug | Idiopathic short stature (ISS), Turner Syndrome (TS), growth hormone deficiency(GHD), others, small for gestational age (SGA) |
Primary outcome
the change in height standard deviation score
Time frame: 3-10years
final adult height standard deviation score- height standard deviation score before treatment
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 4 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Growth Hormone Treatment
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 3
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
PIK3CA Mutation, HER2- Negative Breast Cancer
Active, not recruitingPhase 3
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
Early Breast Cancer
Active, not recruitingPhase 3
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
Breast Cancer
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
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.
Bingyan Cao, Dr. principal investigator
Beijing Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Treatment and Growth Disorders, run by Beijing Children's Hospital 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 1 inclusion and 1 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 4 Sep 2025. 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.
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 Chunxiu Gong, Dr. (13370115001, chunxiugong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in height standard deviation score (time frame: 3-10years). 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 4 Sep 2025.