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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Growth Hormone Deficiency; Chronic Renal Failure; Turner Syndrome; Small for Gestational Age; Idiopathic Short Stature

• Study Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

• Study Contact: Name: YoungHwan Jang; Phone Number: 82-2-6924-3158; Email: younghj@lgls.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: CH Shin, M.D.
    • Principal Investigator: CH Shin, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children with GHD, TS, CRF, SGA and ISS

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
growth hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety measure : adverse event	up to 2 years after epiphyseal closure

Secondary Outcome Measures

Outcome Measure	Time Frame
effectiveness measure : difference in target height and final height	up to 2 years after epiphyseal closure
effectiveness : difference in height velocity between Baseline and every year	up to 2 years after epiphyseal closure
effectiveness measure : difference in height SDS for CA between baseline and every 6 months	up to 2 years after epiphyseal closure

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Principal Investigator: HW Chae, M.D., Kangnam Severance Hospital; Principal Investigator: KS Sim, M.D., Kangdong KyungHee University Hospital; Principal Investigator: IT Hwang, M.D., Kangdong Sacred Heart Hospital; Principal Investigator: SC Chung, M.D., Konkook University hospital; Principal Investigator: CW Ko, M.D., Kyungpook National University Hospital; Principal Investigator: HS Kim, M.D., Keimyung University Hospital; Principal Investigator: YJ Lee, M.D., Korea University; Principal Investigator: KH Lee, M.D., Korea University Anam Hospital; Principal Investigator: JH Lee, M.D., Kosin University Hospital; Principal Investigator: JS Yu, M.D., Dankook University; Principal Investigator: JH Yu, M.D., Dong-A University Hospital; Principal Investigator: SY Lee, M.D., SMG-SNU Boramae Medical Center; Principal Investigator: WY Chung, M.D., Inje University; Principal Investigator: Yl Shin, M.D., Buchun Soonchunhyang university hospital; Principal Investigator: CY Kim, M.D., daejin medical center; Principal Investigator: DK Jin, M.D., Samsung Medical Center; Principal Investigator: MJ Park, M.D., Inje University; Study Chair: CH Shin, M.D., Seoul National University Hospital; Principal Investigator: BK Suh, M.D., Seoul St. Mary's Hospital; Principal Investigator: HW Yoo, M.D., Asan Medical Center; Principal Investigator: MH Jung, M.D., Yeouide St. Mary's hospital; Principal Investigator: SH Park, M.D., St Vincent's Hospital; Principal Investigator: DH Kim, M.D., Sowha children's hospital; Principal Investigator: DH Lee, M.D., Seoul Soonchunhyang university hospital; Principal Investigator: HS Kim, M.D., Sinchon Severance Hospital; Principal Investigator: JS Hwang, M.D., Ajou University School of Medicine; Principal Investigator: SY Kim, M.D., Pusan National University Yangsan Hospital; Principal Investigator: JD Kim, M.D., Wonkwang University School of Medicine & Hospital; Principal Investigator: HS Han, M.D., Chungbuk National University Hospital; Principal Investigator: KH Lee, M.D., Wonkwang University Sanbon Medical Center; Principal Investigator: EK Yoo, M.D., Bunsangcha hospital; Principal Investigator: BK Lim, M.D., Wonju Christian Hospital; Principal Investigator: JH Kang, M.D., Eulji University Hospital; Principal Investigator: JY Seo, M.D., Eulji General Hospital; Principal Investigator: HS Kim, M.D., ehwa university medical center; Principal Investigator: JE Lee, M.D., Inha University Hospital; Principal Investigator: JH Kim, M.D., Inje University; Principal Investigator: CJ Kim, M.D., Chonnam National University Hospital; Principal Investigator: DY Lee, M.D., Chonbuk National University Hospital; Principal Investigator: KS Shin, M.D., Jeju National University Hospital; Principal Investigator: IT Hwang, M.D., Hallym University Medical Center; Principal Investigator: SM Lee, M.D., Hanyang University; Principal Investigator: KH Lee, M.D., Korea University Guro Hospital; Principal Investigator: KS Jo, M.D., Bucheon St. Mary's Hospital; Principal Investigator: SY Ahn, M.D., Kangwon National University Hospital; Principal Investigator: PS Oh, M.D., Chuncheon Sacred Heart Hospital; Principal Investigator: S Yang, M.D., Hallym University Kangnam Sacred Heart Hospital; Principal Investigator: EY Kim, M.D., Chosun university hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 31, 2032
• Study Completion (Anticipated): December 31, 2032

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: May 22, 2012
• First Posted (Estimate): May 23, 2012

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: CRF; PWS; TS; GHD; ISS; SGA
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Renal Insufficiency; Genetic Diseases, Inborn; Musculoskeletal Diseases; Bone Diseases; Renal Insufficiency, Chronic; Heart Defects, Congenital; Cardiovascular Abnormalities; Chromosome Disorders; Bone Diseases, Developmental; Sex Chromosome Disorders; Sex Chromosome Disorders of Sex Development; Kidney Failure, Chronic; Turner Syndrome; Gonadal Dysgenesis; Dwarfism
• Other Study ID Numbers: LG-HGOS001