Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
Study NCT ID:
NCT01604395
Status:
RECRUITING
Last Update Posted:
2021-02-21
First Post:
2012-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}, {'id': 'D014424', 'term': 'Turner Syndrome'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006059', 'term': 'Gonadal Dysgenesis'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D058533', 'term': 'Sex Chromosome Disorders of Sex Development'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2012-05-21', 'studyFirstSubmitQcDate': '2012-05-22', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety measure : adverse event', 'timeFrame': 'up to 2 years after epiphyseal closure'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['GHD', 'TS', 'CRF', 'SGA', 'ISS', 'PWS'], 'conditions': ['Growth Hormone Deficiency', 'Turner Syndrome', 'Chronic Renal Failure', 'Small for Gestational Age', 'Idiopathic Short Stature']}, 'referencesModule': {'references': [{'pmid': '39901524', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '39676465', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '35472208', 'type': 'DERIVED', '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.'}, {'pmid': '35315601', 'type': 'DERIVED', '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.'}, {'pmid': '32419399', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children with GHD, TS, CRF, SGA and ISS', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* short stature children aged 2 years or more\n* children with GHD,TS, CRF, SGA or ISS\n* written informed consent from the person, person's parent or legal guardian"}, 'identificationModule': {'nctId': 'NCT01604395', 'acronym': 'LGS', 'briefTitle': 'Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Chem'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'LG-HGOS001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'growth hormone'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'CH Shin, M.D.', 'role': 'CONTACT'}, {'name': 'CH Shin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'YoungHwan Jang', 'role': 'CONTACT', 'email': 'younghj@lgls.com', 'phone': '82-2-6924-3158'}], 'overallOfficials': [{'name': 'HW Chae, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kangnam severance hospital'}, {'name': 'KS Sim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kangdong KyungHee University hospital'}, {'name': 'IT Hwang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kangdong Sacred Heart Hospital'}, {'name': 'SC Chung, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konkook University hospital'}, {'name': 'CW Ko, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Hospital'}, {'name': 'HS Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keimyung University hospital'}, {'name': 'YJ Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University'}, {'name': 'KH Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}, {'name': 'JH Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kosin university hospital'}, {'name': 'JS Yu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dankook University'}, {'name': 'JH Yu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dong-A University Hospital'}, {'name': 'SY Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}, {'name': 'WY Chung, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University'}, {'name': 'Yl Shin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Buchun Soonchunhyang university hospital'}, {'name': 'CY Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'daejin medical center'}, {'name': 'DK Jin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}, {'name': 'MJ Park, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University'}, {'name': 'CH Shin, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'BK Suh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}, {'name': 'HW Yoo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}, {'name': 'MH Jung, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Yeouide St. Mary's hospital"}, {'name': 'SH Park, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Vincent's Hospital"}, {'name': 'DH Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Sowha children's hospital"}, {'name': 'DH Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul Soonchunhyang university hospital'}, {'name': 'HS Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sinchon severance hospital'}, {'name': 'JS Hwang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}, {'name': 'SY Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Yangsan Hospital'}, {'name': 'JD Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wonkwang university school of medicine & hospital'}, {'name': 'HS Han, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chungbuk National University Hospital'}, {'name': 'KH Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wonkwang University Sanbon Medical Center'}, {'name': 'EK Yoo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bunsangcha hospital'}, {'name': 'BK Lim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wonju Christian Hospital'}, {'name': 'JH Kang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eulji University Hospital'}, {'name': 'JY Seo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eulji General Hospital'}, {'name': 'HS Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ehwa university medical center'}, {'name': 'JE Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inha University Hospital'}, {'name': 'JH Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University'}, {'name': 'CJ Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam National University Hospital'}, {'name': 'DY Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk National University Hospital'}, {'name': 'KS Shin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jeju National University Hospital'}, {'name': 'IT Hwang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hallym University Medical Center'}, {'name': 'SM Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University'}, {'name': 'KH Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Guro Hospital'}, {'name': 'KS Jo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Bucheon St. Mary's Hospital"}, {'name': 'SY Ahn, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KangWon National University Hospital'}, {'name': 'PS Oh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chuncheon Sacred Heart Hospital'}, {'name': 'S Yang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hallym University Kangnam Sacred Heart Hospital'}, {'name': 'EY Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chosun University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Chem', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}