Evaluating long-term safety and effectiveness of growth hormone in children with various conditions
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
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 |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | LG Chem Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT01604395 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown varying degrees of success with growth hormone therapy in similar populations, indicating a potential for positive outcomes.
Eligibility criteria
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 this trial is running
Seoul
- 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
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.