ClinicalTrials.gg
RecruitingNCT01604395LGSUpdated Feb 21, 2021

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

An observational study in Growth Hormone Deficiency, Turner Syndrome and Chronic Renal Failure, sponsored by LG Chem. Recruiting at 1 site in Korea, Republic of. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2021-02-21.

Sponsored by LG Chem · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
6,000
Ages
2 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Growth Hormone Deficiency
  • Turner Syndrome
  • Chronic Renal Failure
  • Small for Gestational Age
  • Idiopathic Short Stature

Keywords

  • GHD
  • TS
  • CRF
  • SGA
  • ISS
  • PWS
03

In context

Dwarfism, Pituitary

252 studies on the registry are indexed under Dwarfism, Pituitary; 30 are open to participants now.

This study's planned enrollment of 6,000 is above the median of 70 across 73 observational studies indexed under Dwarfism, Pituitary.

Browse Dwarfism, Pituitary studies →

Lead sponsor

LG Chem is the lead sponsor of 71 studies on the registry; 8 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

children with GHD, TS, CRF, SGA and ISS

Eligibility criteria

Inclusion Criteria:

  • short stature children aged 2 years or more
  • children with GHD,TS, CRF, SGA or ISS
  • written from the person, person's parent or legal guardian
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
6,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • growth hormone
06

What researchers measure

Primary outcomes

  1. Safety measure : adverse event

    Time frame: up to 2 years after epiphyseal closure

Secondary outcomes

  1. effectiveness measure : difference in target height and final height

    Time frame: up to 2 years after epiphyseal closure

  2. effectiveness : difference in height velocity between Baseline and every year

    Time frame: up to 2 years after epiphyseal closure

  3. effectiveness measure : difference in height SDS for CA between baseline and every 6 months

    Time frame: up to 2 years after epiphyseal closure

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, Korea, Republic of
    Recruiting
    • CH Shin, M.D. · Contact
    • CH Shin, M.D. · Principal investigator
08

References and documents

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. PubMed 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. PubMed 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. PubMed 32419399 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2012, a primary completion of Dec 2032 and a completion of Dec 2032. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 21, 2012
First posted
May 23, 2012
Start
Jan 2012
Primary completionEst.
Dec 31, 2032
CompletionEst.
Dec 31, 2032
Last update
Feb 21, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01604395
Lead sponsor
LG Chem
Responsible party
Sponsor
First posted
May 23, 2012
Start date
Jan 2012
Primary completion
Dec 31, 2032 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Feb 21, 2021

Study contacts

YoungHwan Jang
Contact
younghj@lgls.com
82-2-6924-3158
HW Chae, M.D.
principal investigator · Kangnam severance hospital
KS Sim, M.D.
principal investigator · Kangdong KyungHee University hospital
IT Hwang, M.D.
principal investigator · Kangdong Sacred Heart Hospital
SC Chung, M.D.
principal investigator · Konkook University hospital
CW Ko, M.D.
principal investigator · Kyungpook National University Hospital
HS Kim, M.D.
principal investigator · Keimyung University hospital
YJ Lee, M.D.
principal investigator · Korea University
KH Lee, M.D.
principal investigator · Korea University Anam Hospital
JH Lee, M.D.
principal investigator · Kosin university hospital
JS Yu, M.D.
principal investigator · Dankook University
JH Yu, M.D.
principal investigator · Dong-A University Hospital
SY Lee, M.D.
principal investigator · SMG-SNU Boramae Medical Center
WY Chung, M.D.
principal investigator · Inje University
Yl Shin, M.D.
principal investigator · Buchun Soonchunhyang university hospital
CY Kim, M.D.
principal investigator · daejin medical center
DK Jin, M.D.
principal investigator · Samsung Medical Center
MJ Park, M.D.
principal investigator · Inje University
CH Shin, M.D.
study chair · Seoul National University Hospital
BK Suh, M.D.
principal investigator · Seoul St. Mary's Hospital
HW Yoo, M.D.
principal investigator · Asan Medical Center
MH Jung, M.D.
principal investigator · Yeouide St. Mary's hospital
SH Park, M.D.
principal investigator · St Vincent's Hospital
DH Kim, M.D.
principal investigator · Sowha children's hospital
DH Lee, M.D.
principal investigator · Seoul Soonchunhyang university hospital
HS Kim, M.D.
principal investigator · Sinchon severance hospital
JS Hwang, M.D.
principal investigator · Ajou University School of Medicine
SY Kim, M.D.
principal investigator · Pusan National University Yangsan Hospital
JD Kim, M.D.
principal investigator · Wonkwang university school of medicine & hospital
HS Han, M.D.
principal investigator · Chungbuk National University Hospital
KH Lee, M.D.
principal investigator · Wonkwang University Sanbon Medical Center
EK Yoo, M.D.
principal investigator · Bunsangcha hospital
BK Lim, M.D.
principal investigator · Wonju Christian Hospital
JH Kang, M.D.
principal investigator · Eulji University Hospital
JY Seo, M.D.
principal investigator · Eulji General Hospital
HS Kim, M.D.
principal investigator · ehwa university medical center
JE Lee, M.D.
principal investigator · Inha University Hospital
JH Kim, M.D.
principal investigator · Inje University
CJ Kim, M.D.
principal investigator · Chonnam National University Hospital
DY Lee, M.D.
principal investigator · Chonbuk National University Hospital
KS Shin, M.D.
principal investigator · Jeju National University Hospital
IT Hwang, M.D.
principal investigator · Hallym University Medical Center
SM Lee, M.D.
principal investigator · Hanyang University
KH Lee, M.D.
principal investigator · Korea University Guro Hospital
KS Jo, M.D.
principal investigator · Bucheon St. Mary's Hospital
SY Ahn, M.D.
principal investigator · KangWon National University Hospital
PS Oh, M.D.
principal investigator · Chuncheon Sacred Heart Hospital
S Yang, M.D.
principal investigator · Hallym University Kangnam Sacred Heart Hospital
EY Kim, M.D.
principal investigator · Chosun University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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