Growth Hormone DeficiencyLGSNCT01604395
Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children
An observational study of Growth Hormone Deficiency and Turner Syndrome, run by LG Chem at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure
- How many people
- 6,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: children with GHD, TS, CRF, SGA and ISS
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
CH Shin, M.D.
CH Shin, M.D.
About this study
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
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).
- Conditions
- Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age, Idiopathic Short Stature
- Keywords
- GHD, TS, CRF, SGA, ISS, PWS
- Medical subject headings
- Dwarfism, Pituitary, Turner Syndrome, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| growth hormone | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measure : adverse event
Measured: up to 2 years after epiphyseal closure
Secondary outcomes (3)
effectiveness measure : difference in target height and final height
Measured: up to 2 years after epiphyseal closure
effectiveness : difference in height velocity between Baseline and every year
Measured: up to 2 years after epiphyseal closure
effectiveness measure : difference in height SDS for CA between baseline and every 6 months
Measured: up to 2 years after epiphyseal closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startJan 2012
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- HW Chae, M.D., Principal investigator, Kangnam severance hospitalKS Sim, M.D., Principal investigator, Kangdong KyungHee University hospitalIT Hwang, M.D., Principal investigator, Kangdong Sacred Heart HospitalSC Chung, M.D., Principal investigator, Konkook University hospitalCW Ko, M.D., Principal investigator, Kyungpook National University HospitalHS Kim, M.D., Principal investigator, Keimyung University hospitalYJ Lee, M.D., Principal investigator, Korea UniversityKH Lee, M.D., Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604395
- Sponsor's protocol ID
- LG-HGOS001
- Acronym
- LGS
- Status last verified
- Feb 2021
- First submitted
- 21 May 2012
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 41493505Kim 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.
PubMed 39901524Jeong 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.
PubMed 39676465Lee 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 35472208Lim 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 35315601Cho 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01604395
- Acronym / sponsor ID
- LGS / LG-HGOS001
- Conditions
- Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age, Idiopathic Short Stature
- Keywords
- GHD, TS, CRF, SGA, ISS, PWS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 23 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| growth hormone | – | – |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children with GHD, TS, CRF, SGA and ISS
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety measure : adverse event
Time frame: up to 2 years after epiphyseal closure
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 41493505Lee 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.
- Derived from this study: PubMed 39901524Kim 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.
- Derived from this study: PubMed 39676465Jeong 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.
- Derived from this study: PubMed 35472208Lee 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.
- Derived from this study: PubMed 35315601Lim 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.
- Derived from this study: PubMed 32419399Cho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency and Turner Syndrome, run by LG Chem at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YoungHwan Jang (82-2-6924-3158, younghj@lgls.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measure : adverse event (time frame: up to 2 years after epiphyseal closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01604395, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.