NCT01604395 (LGS) is a clinical trial in Growth Hormone Deficiency, sponsored by LG Chem.

Who is sponsoring NCT01604395?

NCT01604395 is sponsored by LG Chem.

What condition does NCT01604395 study?

NCT01604395 studies Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age, Idiopathic Short Stature.

Is NCT01604395 still recruiting?

NCT01604395 is currently recruiting now. Last updated 17 February 2021.

Last reviewed 2021-02-17 · How we verify

NCT01604395: LGS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Last updated 17 February 2021

What this trial tests

trial in Growth Hormone Deficiency in 6,000 participants. Currently enrolling.

Timeline

1 January 2012

Primary endpoint
31 December 2032

31 December 2032

Quick facts

Lead sponsor	LG Chem
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	6,000
Start date	1 January 2012
Primary completion	31 December 2032
Estimated completion	31 December 2032
Sites	1 location across South Korea

Conditions studied

Growth Hormone Deficiency — all drugs for Growth Hormone Deficiency →
Turner Syndrome — all drugs for Turner Syndrome →
Chronic Renal Failure — all drugs for Chronic Renal Failure →
Small for Gestational Age — all drugs for Small for Gestational Age →

Sponsor

LG Chem — full company profile →

Who can join

2 and older, any sex, with Growth Hormone Deficiency or Turner Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety measure : adverse event
Time frame: up to 2 years after epiphyseal closure

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Long-term safety and effectiveness of growth hormone therapy in Korean children with growth disorders: 5-year results of LG Growth Study.
Rhie YJ, Yoo JH, Choi JH, Chae HW, et al · · 2019 · cited 34× · PMID 31095622 · DOI 10.1371/journal.pone.0216927
Design of the long-term observational cohort study with recombinant human growth hormone in Korean children: LG Growth Study.
Chung S, Yoo JH, Choi JH, Rhie YJ, et al · · 2018 · cited 21× · PMID 29609449 · DOI 10.6065/apem.2018.23.1.43
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.
Lim HH, Kim YM, Lee GM, Yu J, et al · · 2022 · cited 8× · PMID 35315601 · DOI 10.3346/jkms.2022.37.e90
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.
Cho WK, Ahn MB, Kim EY, Cho KS, et al · · 2020 · cited 8× · PMID 32419399 · DOI 10.3346/jkms.2020.35.e151
Factors affecting IGF-I level and correlation with growth response during growth hormone treatment in LG Growth Study.
Kim JH, Kim SJ, Lee J, Shin CH, et al · · 2021 · cited 7× · PMID 34280192 · DOI 10.1371/journal.pone.0252283
Association between uric acid and height during growth hormone therapy in children with idiopathic short stature.
Yoon JS, Seo YJ, Kwon EB, Lee HJ, et al · · 2022 · cited 6× · PMID 36531458 · DOI 10.3389/fendo.2022.1025005
Long-term effectiveness of growth hormone therapy in children born small for gestational age: An analysis of LG growth study data.
Lee HS, Kum CD, Rho JG, Hwang JS. · · 2022 · cited 6× · PMID 35472208 · DOI 10.1371/journal.pone.0266329
Comparison of growth hormone therapy response according to the presence of growth hormone deficiency in children born small for gestational age with short stature in Korea: a retrospective cohort study.
Jo HY, Jang HJ, Cheon CK, Yoon JY, et al · · 2025 · cited 3× · PMID 39893395 · DOI 10.1186/s12887-024-05339-0

Verify or expand the search:

Other recruiting trials for Growth Hormone Deficiency

Currently open trials in the same condition.

NCT06542809 — Evaluation of the Propensity of Patients Under rhGH to Envision a Modification of Their Treatment Regimen Toward LAGH · NA · recruiting
NCT05681299 — Effects of GH and Lirglutide on AgRP · Phase 4 · recruiting
NCT06455956 — Use of miRNAs in Growth Hormone Deficiency (GHD) · recruiting

Other LG Chem trials

Trials by the same sponsor.

NCT07396844 — The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Voluntee · Phase 1 · not yet recruiting
NCT07399470 — A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagl · Phase 1 · active not recruiting
NCT07333742 — A Clinical Study to See How the Body Handles and How Safe a Combination Tablet of Gemigliptin, Dapagliflozin, and Metfor · Phase 1 · completed
NCT06921395 — Phase IV Study to Evaluate the Efficacy and Safety of Fang Le Shu Compared to Guo Na Fen for Controlled Ovarian Stimulat · Phase 4 · recruiting
NCT06743997 — A Study to Compare Eutropin Formulations in Healthy Volunteers for Bioavailability, Safety, and Tolerability · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01604395 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LG Chem
Last refreshed: 17 February 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01604395.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing