Evaluating the long-term safety and effectiveness of Growtropin®-II in children with short stature
Open, Multi-center, Non-interventional, Prospective/ Retrospective Observational Study on Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
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 |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Dong-A ST Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul, Seodaemun-gu) |
| Trial ID | NCT04798690 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Children who have experienced epiphyseal closure will not benefit from this study.
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 performed: Other studies evaluating growth hormone treatments have shown promising results, indicating that this approach is supported by previous research.
Eligibility criteria
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 this trial is running
Seoul, Seodaemun-gu
- 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
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.