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Recruiting NCT06110910

Long-term Efficacy and Safety Evaluation of Growth Hormone in Children in China(CGLS)

— Observational Childhood Short Stature

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Polvethylene glycol recombinant human growth hormone injection (PEG-rhGH) or recombinanthuman growth hormone injection (rhGH).
Who it may be relevant to
Registry conditions: Childhood Short Stature. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Long-term Efficacy and Safety Evaluation of Growth Hormone in Children in China(CGLS)-an Open-label, Multicenter, Prospective and Retrospective Observational Study

Overview

Short stature is a relatively common pediatric condition, referring to individuals whose height is more than 2 (-2 SD) standard deviations below the average height of a similar age, gender, and ethnicity population in similar living conditions, or those below the third percentile (-1.88 SD). This study is an open-label, multicenter, prospective and retrospective, observational, cohort study aimed at assessing the long-term safety and efficacy of PEG-rhGH or rhGH treatment for Chinese children with short stature. The study is divided into retrospective cohorts, retrospective prospective cohorts, and prospective cohorts. It is expected to include approximately 10000 patients (including around 3000 in the retrospective cohorts and around 7000 in the retrospective prospective and prospective cohorts). The total duration is expected to be 16 years, including 2 years for study center initiation and patient recruitment and follow-up of patients in the retrospective prospective and prospective cohorts until near-adult height (NAH). The primary objective is to evaluate the long-term safety of PEG-rhGH or rhGH for the treatment of children with short stature (including GHD, ISS, SGA, TS, PWS, NS, SHOX gene deletion, and other etiologies); the secondary objective is to assess the effectiveness of PEG-rhGH or rhGH treatment for children with short stature (including GHD, ISS, SGA, TS, PWS, NS, SHOX gene deletion, and other etiologies).

Interventions

  • Drug Polvethylene glycol recombinant human growth hormone injection (PEG-rhGH) or recombinanthuman growth hormone injection (rhGH)
    Polvethylene glycol recombinant human growth hormone injection (PEG-rhGH) and recombinanthuman growth hormone injection (rhGH) were used.

Primary outcome measures

  • The AE (Adverse Event) and SAE (Serious Adverse Event) occurrence rates [Time frame: From the time of signing the informed consent form to the near adult height(NAH), the overall assessment time was approximately 192 months.]

Eligibility criteria

Inclusion criteria

  • Children aged 2 years and older with various causes of short stature.
  • Height below the 3rd percentile (-1.88 SD) compared to the height of normal, healthy children of the same age and gender.
  • Belonging to one of the following indications: GHD, ISS, SGA, TS, PWS, NS, SHOX gene deletion, or other causes of short stature.

Note: In this study, the inclusion criteria for the PWS cohort do not impose restrictions on height and age at the start of treatment.

Exclusion criteria

  • Patients with fully closed growth plates.
  • Patients with signs of potential tumor progression or those already diagnosed with tumors.
  • Allergic reactions to growth hormone or its adjuvants.
  • Patients who have received any growth hormone treatment other than the investigational drug in the six months prior to screening.
  • Any other circumstances deemed unsuitable for study inclusion by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • TongjiHospital — Wuhan

Publications

  • Wu W, Luo X. Long-Term Efficacy and Safety of Growth Hormone in Children Suffering from Short Stature in China (CGLS): An Open-Label, Multicenter, Prospective and Retrospective, Observational Study. Adv Ther. 2025 Jun;42(6):2957-2969. doi: 10.1007/s12325-025-03146-2. Epub 2025 Apr 8. PMID 40198521

Identifiers

NCT: NCT06110910 · TJ-IRB202410048

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗