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Recruiting NCT01604395

Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children

Observational Growth Hormone Deficiency Turner Syndrome Chronic Renal Failure Small for Gestational Age

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

The purpose of this study is to evaluate the long-term safety and effectiveness of growth hormone (Eutropin Inj./Eutropin plus Inj.) treatment with GHD (Growth Hormone Deficiency), TS (Turner Syndrome),CRF (Chronic Renal Failure), SGA (Small for Gestational Age), and ISS (Idiopathic Short Stature).

Primary outcome measures

  • Safety measure : adverse event [Time frame: up to 2 years after epiphyseal closure]
Secondary outcome measures (3)
  • effectiveness measure : difference in target height and final height [Time frame: up to 2 years after epiphyseal closure]
  • effectiveness : difference in height velocity between Baseline and every year [Time frame: up to 2 years after epiphyseal closure]
  • effectiveness measure : difference in height SDS for CA between baseline and every 6 months [Time frame: up to 2 years after epiphyseal closure]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Publications

  • Lee HS, Rhie YJ, Kim J, Chae HW, Lee YA, Kim YM, Kim JH, Hong YH, Ahn MB, Hwang JS. Long-Term experience with growth hormone therapy in pediatric growth disorders: an analysis of the LG growth study data. Endocrine. 2026 Jan 6;91(1):31. doi: 10.1007/s12020-025-04535-x. PMID 41493505
  • Kim JH, Kim SJ, Chung IH, Lim JS. Adiposity Rebound Timing in Small for Gestational Age Children Treated With Growth Hormone: Results From LG Growth Study Data. J Korean Med Sci. 2025 Feb 3;40(4):e12. doi: 10.3346/jkms.2025.40.e12. PMID 39901524
  • Jeong HR, Lee HS, Hwang JS. Growth Prediction Model for Prepubertal Children With Idiopathic Growth Hormone Deficiency: An Analysis of LG Growth Study Data. Clin Endocrinol (Oxf). 2025 Mar;102(3):281-287. doi: 10.1111/cen.15178. Epub 2024 Dec 15. PMID 39676465
  • Lee HS, Kum CD, Rho JG, Hwang JS. Long-term effectiveness of growth hormone therapy in children born small for gestational age: An analysis of LG growth study data. PLoS One. 2022 Apr 26;17(4):e0266329. doi: 10.1371/journal.pone.0266329. eCollection 2022. PMID 35472208
  • Lim HH, Kim YM, Lee GM, Yu J, Han HS, Yu J. Growth Responses During 3 Years of Growth Hormone Treatment in Children and Adolescents With Growth Hormone Deficiency: Comparison Between Idiopathic, Organic and Isolated Growth Hormone Deficiency, and Multiple Pituitary Hormone Deficiency. J Korean Med Sci. 2022 Mar 21;37(11):e90. doi: 10.3346/jkms.2022.37.e90. PMID 35315601
  • Cho WK, Ahn MB, Kim EY, Cho KS, Jung MH, Suh BK. Predicting First-Year Growth in Response to Growth Hormone Treatment in Prepubertal Korean Children with Idiopathic Growth Hormone Deficiency: Analysis of Data from the LG Growth Study Database. J Korean Med Sci. 2020 May 18;35(19):e151. doi: 10.3346/jkms.2020.35.e151. PMID 32419399

Identifiers

NCT: NCT01604395 · LG-HGOS001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗