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RecruitingNCT06037473Updated Sep 4, 2025

The Efficacy and Safety of PEGylated GH for the Treatment of Short Stature in Chinese Children-GLOBE Reg

An observational study in Growth Hormone Treatment and Growth Disorders, sponsored by Beijing Children's Hospital. Recruiting at 1 site in China. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Beijing Children's Hospital · Observational

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,600
Ages
Up to 18 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Growth Hormone Treatment
  • Growth Disorders

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03

In context

Growth Disorders

167 studies on the registry are indexed under Growth Disorders; 24 are open to participants now.

This study's planned enrollment of 2,600 is above the median of 205 across 67 observational studies indexed under Growth Disorders.

Browse Growth Disorders studies →

Lead sponsor

Beijing Children's Hospital is the lead sponsor of 51 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Inclusion criteria

Patients with endogenous growth hormone deficiency, Turner Syndrome, SGA, idiopathic short stature, etc. treated with polyethylene glycol recombinant human growth hormone injection

Exclusion criteria

Exclusion Criteria:

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;

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,600 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    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.

    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.

    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.

    Drug: Polyethylene glycol recombinant human growth hormone injection

Interventions

  • DrugPolyethylene glycol recombinant human growth hormone injection

    0.1-0.3mg/kg.w

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What researchers measure

Primary outcomes

  1. the change in height standard deviation score

    final adult height standard deviation score- height standard deviation score before treatment

    Time frame: 3-10years

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Study locations

1 of 1 sites recruiting
  • Department of Endocrinology, Genetics, Metabolism
    Beijing, Beijing Municipality 010, China
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06037473
Lead sponsor
Beijing Children's Hospital
Collaborators
University of Glasgow
Responsible party
Chunxiu Gong (Principal Investigator, Beijing Children's Hospital) — Principal investigator
First posted
Sep 14, 2023
Start date
Aug 1, 2023
Primary completion
Jan 1, 2029 (estimated)
Completion
Aug 1, 2029 (estimated)
Last update
Sep 4, 2025

Study contacts

Chunxiu Gong, Dr.
Contact
chunxiugong@163.com
13370115001
Jiajia Chen, Dr.
Contact
chenjiaj2009@126.com
13810773718
Bingyan Cao, Dr.
principal investigator · Beijing Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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