NCT01604395

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
81mo left

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jan 2012Dec 2032

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
20.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

21 years

First QC Date

May 21, 2012

Last Update Submit

February 17, 2021

Conditions

Keywords

GHDTSCRFSGAISSPWS

Outcome Measures

Primary Outcomes (1)

  • Safety measure : adverse event

    up to 2 years after epiphyseal closure

Secondary Outcomes (3)

  • 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

Study Arms (1)

growth hormone

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

children with GHD, TS, CRF, SGA and ISS

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (5)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Dwarfism, PituitaryTurner SyndromeKidney Failure, Chronic

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesGonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSex Chromosome Disorders of Sex DevelopmentMale Urogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSex Chromosome DisordersChromosome DisordersGenetic Diseases, InbornGonadal DisordersRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • CH Shin, M.D.

    Seoul National University Hospital

    STUDY CHAIR
  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YoungHwan Jang

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 23, 2012

Study Start

January 1, 2012

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations