Evaluating the long-term safety and effectiveness of Growtropin®-II in children with short stature
Official title: Open, Multi-center, Non-interventional, Prospective/ Retrospective Observational Study on Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
Run by Dong-A ST Co., Ltd. · NCT04798690 · Data updated 2026-11-12
This study is testing whether the Growtropin®-II treatment is safe and effective for children with short stature caused by various conditions, to see how it helps them grow and stay healthy over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years and up |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Dong-A ST Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul, Seodaemun-gu) |
| Status | Recruiting |
| Started | February 8, 2021 |
| Main results expected | February 2035 |
| Study ends | February 2035 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT04798690 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children diagnosed with short stature due to specific conditions like growth hormone deficiency, idiopathic short stature, Turner syndrome, or being small for gestational age.
✕Probably not a fit
Children who have experienced epiphyseal closure will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study assesses the long-term safety and effectiveness of Growtropin®-II treatment in children diagnosed with short stature due to growth hormone deficiency, idiopathic short stature, Turner syndrome, or being small for gestational age. The study includes children who have an official height record from at least six months prior to participation. By monitoring these children over time, the study aims to gather valuable data on the treatment's impact on growth and overall health.
Why it matters
Potential benefit: If successful, this study could provide insights into effective long-term treatment options for children with short stature.
How similar studies have gone: Other studies evaluating growth hormone treatments have shown promising results, indicating that this approach is supported by previous research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children with short stature by growth hormone deficiency(GHD) or idiopathic short stature (ISS) or turner's syndrome(TS) or small for gestational age(SGA) * Children who has official height record at least 6 months prior Exclusion Criteria: * Children with Epiphyseal closure
Where it's running
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Yonsei University Health System, Severance Hospital
Seoul, Seodaemun-gu, South Korea Recruiting
Study contacts
- Study coordinator: Sung
- Email: jhsung@donga.co.kr
- Phone: +82-2-920-8369
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating long-term safety and effectiveness of growth hormone in children with various conditions
This study is testing how safe and effective growth hormone treatment is for children with conditions like Growth Hormone Deficiency and Turner Syndrome over the long term.
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Once-weekly lonapegsomatropin versus daily somatropin for children and adolescents with short stature due to growth-hormone-sufficient conditions
It will test whether a once-weekly injection of lonapegsomatropin helps children and teens with Turner syndrome, SHOX mutation, small-for-gestational-age, or idiopathic short stature grow as well as or better than daily somatropin.
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Long-term Inpegsomatropin Treatment for Idiopathic Short Stature: Extension of Phase III Study
This extension study tests whether continuing Inpegsomatropin injections helps kids with Idiopathic Short Stature who finished a prior phase 3 trial.
-
Understanding growth hormone deficiency after a brain injury in adults
This observational study tests whether growth hormone deficiency affects quality of life and symptoms in adults with traumatic brain injury and whether GH replacement helps after 12 weeks.
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Inpegsomatropin vs Givopegsomatropin for short stature in girls with Turner syndrome
A 52-week, multicenter, randomized study tests whether Inpegsomatropin injections help prepubertal girls with Turner syndrome grow taller compared with a known treatment.
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Parental plans and pregnancy outcomes in 93 women with Turner syndrome
This project describes parental plans and pregnancy outcomes for adult women with Turner syndrome treated at Strasbourg University Hospitals between 2009 and 2019.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.