Clinical trial NCT01604395: Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Growth Hormone Deficiency
Turner Syndrome
Chronic Renal Failure
Small for Gestational Age
Idiopathic Short Stature
Keywords: GHD
TS
CRF
SGA
ISS
PWS
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2012-05-23
Enrollment: 6000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with GHD, TS, CRF, SGA and ISS

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).


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

Primary outcomes:
measure: Safety measure : adverse event
timeFrame: up to 2 years after epiphyseal closure
Secondary outcomes:
measure: effectiveness measure : difference in target height and final height
timeFrame: up to 2 years after epiphyseal closure
measure: effectiveness : difference in height velocity between Baseline and every year
timeFrame: up to 2 years after epiphyseal closure
measure: effectiveness measure : difference in height SDS for CA between baseline and every 6 months
timeFrame: up to 2 years after epiphyseal closure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Kangnam severance hospital
name: HW Chae, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangdong KyungHee University hospital
name: KS Sim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangdong Sacred Heart Hospital
name: IT Hwang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Konkook University hospital
name: SC Chung, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Hospital
name: CW Ko, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyung University hospital
name: HS Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University
name: YJ Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Anam Hospital
name: KH Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kosin university hospital
name: JH Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dankook University
name: JS Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dong-A University Hospital
name: JH Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: SMG-SNU Boramae Medical Center
name: SY Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: WY Chung, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Buchun Soonchunhyang university hospital
name: Yl Shin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: daejin medical center
name: CY Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: DK Jin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: MJ Park, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: CH Shin, M.D.
role: STUDY_CHAIR
affiliation: Seoul St. Mary's Hospital
name: BK Suh, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: HW Yoo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeouide St. Mary's hospital
name: MH Jung, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's Hospital
name: SH Park, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sowha children's hospital
name: DH Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul Soonchunhyang university hospital
name: DH Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sinchon severance hospital
name: HS Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University School of Medicine
name: JS Hwang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Yangsan Hospital
name: SY Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang university school of medicine & hospital
name: JD Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungbuk National University Hospital
name: HS Han, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang University Sanbon Medical Center
name: KH Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bunsangcha hospital
name: EK Yoo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonju Christian Hospital
name: BK Lim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eulji University Hospital
name: JH Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eulji General Hospital
name: JY Seo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: ehwa university medical center
name: HS Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: JE Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: JH Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: CJ Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: DY Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jeju National University Hospital
name: KS Shin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Medical Center
name: IT Hwang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: SM Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Guro Hospital
name: KH Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bucheon St. Mary's Hospital
name: KS Jo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: KangWon National University Hospital
name: SY Ahn, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chuncheon Sacred Heart Hospital
name: PS Oh, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Kangnam Sacred Heart Hospital
name: S Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chosun University Hospital
name: EY Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.