Evaluating the long-term effects of growth hormone treatment in children with short stature in China
Long-term Efficacy and Safety Evaluation of Growth Hormone in Children in China(CGLS)-an Open-label, Multicenter, Prospective and Retrospective Observational Study
This study is testing the long-term effects of two types of growth hormone treatments to see how well they work and how safe they are for Chinese children with short stature.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06110910 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term safety and efficacy of polyethylene glycol recombinant human growth hormone (PEG-rhGH) and recombinant human growth hormone (rhGH) in treating Chinese children diagnosed with short stature. The study will include approximately 10,000 patients, divided into retrospective and prospective cohorts, over a total duration of 16 years. It will focus on children aged 2 years and older who fall below the third percentile in height due to various medical conditions. The study will gather data from multiple centers to provide a comprehensive evaluation of treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2 years and older with short stature due to conditions such as growth hormone deficiency, idiopathic short stature, or Turner syndrome.
Not a fit: Patients with fully closed growth plates or those with active tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term benefits and safety of growth hormone treatments for children with short stature.
How similar studies have performed: Other studies have shown positive outcomes with growth hormone treatments in similar pediatric populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Children aged 2 years and older with various causes of short stature. 2. Height below the 3rd percentile (-1.88 SD) compared to the height of normal, healthy children of the same age and gender. 3. 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: 1. Patients with fully closed growth plates. 2. Patients with signs of potential tumor progression or those already diagnosed with tumors. 3. Allergic reactions to growth hormone or its adjuvants. 4. Patients who have received any growth hormone treatment other than the investigational drug in the six months prior to screening. 5. Any other circumstances deemed unsuitable for study inclusion by the investigator.
Where this trial is running
Wuhan, Hubei
- TongjiHospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: xiaoping Luo, doctor — Tongji Hospital
- Study coordinator: xiaoping Luo, doctor
- Email: xpluo@tjh.tjmu.edu.cn
- Phone: 13387522645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.