Evaluating long-term safety and effectiveness of growth hormone in children with various conditions
Official title: An Open, Multi-center, Prospective and Retrospective Observational Study to Evaluate the Long-term Safety and Effectiveness of Growth Hormone (Eutropin Inj. / Eutropin Plus Inj.) Treatment With GHD, TS, CRF, SGA, ISS and PWS in Children
Run by LG Chem · NCT01604395 · Data updated 2026-11-12
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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years and up |
| Sex | All |
| Enrollment | 6000 (estimated) |
| Sponsor | LG Chem Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | January 2012 |
| Main results expected | December 31, 2032 |
| Study ends | December 31, 2032 |
| Registry record updated | February 21, 2021 |
| Trial ID | NCT01604395 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 2 years or older with Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age, or Idiopathic Short Stature.
✕Probably not a fit
Patients who do not have any of the specified conditions or are younger than 2 years old may not receive 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 aims to assess the long-term safety and effectiveness of growth hormone treatment in children diagnosed with Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age, and Idiopathic Short Stature. The study will involve children aged 2 years or older who meet the inclusion criteria and have received informed consent from their guardians. By monitoring these children over time, the study seeks to gather valuable data on the outcomes of growth hormone therapy in these specific populations.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term benefits and safety of growth hormone therapy for children with specific growth-related conditions.
How similar studies have gone: Other studies have shown varying degrees of success with growth hormone therapy in similar populations, indicating a potential for positive outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * short stature children aged 2 years or more * children with GHD,TS, CRF, SGA or ISS * written informed consent from the person, person's parent or legal guardian
Where it's running
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Seoul National University Hospital
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: HW Chae, M.D. — Kangnam severance hospital
- Study coordinator: YoungHwan Jang
- Email: younghj@lgls.com
- Phone: 82-2-6924-3158
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating the long-term safety and effectiveness of Growtropin®-II 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.
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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.
-
Nurse-led programs mixing exercise and psychology to help people with chronic kidney disease
This study tests whether a nurse-led program that combines physical exercise and psychosocial support can improve outcomes for adults with chronic renal failure on dialysis or in hospital.
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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.
-
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.
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.