Long-term Efficacy and Safety Evaluation of Growth Hormone in Children in China(CGLS)
Recruiting now
Conditions studied: Childhood Short Stature
In brief
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).
Key facts
- Study ID
- NCT06110910
- Run by
- Xiaoping Luo
- People needed
- 10000
- Starts
- 2023-03-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2024-11-05
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- TongjiHospital — Wuhan, Hubei, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.