NCT06110910

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

Recruiting now Last updated 5 November 2024

What this trial tests

trial testing Polvethylene glycol recombinant human growth hormone injection (PEG-rhGH) or recombinanthuman growth hormone injection (rhGH) in Childhood Short Stature in 10,000 participants. Currently enrolling.

Timeline

1 March 2023

Primary endpoint
31 December 2027

31 December 2027

Quick facts

Lead sponsor	Xiaoping Luo
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	10,000
Start date	1 March 2023
Primary completion	31 December 2027
Estimated completion	31 December 2027
Sites	1 location across China

Drugs / interventions tested

• Polvethylene glycol recombinant human growth hormone injection (PEG-rhGH) or recombinanthuman growth hormone injection (rhGH)

Conditions studied

• Childhood Short Stature — all drugs for Childhood Short Stature →

Sponsor

Xiaoping Luo

Who can join

2 and older, any sex, with Childhood Short Stature. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Wu W, Luo X. · · 2025 · cited 4× · PMID 40198521 · DOI 10.1007/s12325-025-03146-2
2. Real-Life Growth Hormone Treatment Patterns in Children from China: A Report from Two Databases.
   Wu W, Li N, Wang T, Luo X. · · 2025 · cited 3× · PMID 40439954 · DOI 10.1007/s12325-025-03204-9
3. Comparison between long-acting pegylated and daily recombinant human growth hormone for pediatric growth hormone deficiency a systematic review.
   Zhang J, Guo S, Wang T, Chen Q. · · 2025 · cited 1× · PMID 40702077 · DOI 10.1038/s41598-025-10613-x