Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2026-01-01 @ 9:09 PM
Study NCT ID:
NCT02770157
Status:
COMPLETED
Last Update Posted:
2019-10-16
First Post:
2016-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of DA-3002 in Short Children Borns SGA.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-13', 'studyFirstSubmitDate': '2016-05-10', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in anti-growth hormone antibody', 'timeFrame': '52 weeks'}], 'primaryOutcomes': [{'measure': 'Annualized height velocity(cm/year) after 52 weeks.', 'timeFrame': '52 weeks', 'description': 'Height velocity calculated with height measured at Baseline and after 52 weeks was converted to annual growth rate.'}], 'secondaryOutcomes': [{'measure': 'Annualized height velocity(cm/year) after 26 weeks.', 'timeFrame': '26 weeks', 'description': 'Height velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.'}, {'measure': 'Changes in height standard deviation score after 52 weeks', 'timeFrame': '52 weeks'}, {'measure': 'Changes in bone maturation(changes in bone ages/changes in chronological age) after 52 weeks', 'timeFrame': '52 weeks'}, {'measure': 'Changes in IGF-1 after 52 weeks', 'timeFrame': '52 weeks'}, {'measure': 'Changes in IGFBP-3 after 52 weeks', 'timeFrame': '52 weeks'}]}, 'conditionsModule': {'conditions': ['Infant, Small for Gestational Age']}, 'referencesModule': {'references': [{'pmid': '34397702', 'type': 'DERIVED', 'citation': 'Kim SJ, Kim MS, Cho SY, Suh BK, Ko CW, Lee KH, Yoo HW, Shin CH, Hwang JS, Kim HS, Chung WY, Kim CJ, Han HS, Jin DK. Efficacy and safety of the recombinant human growth hormone in short children born small for gestational age: A randomized, multicentre, comparative phase III trial. Medicine (Baltimore). 2021 Jul 30;100(30):e26711. doi: 10.1097/MD.0000000000026711.'}]}, 'descriptionModule': {'briefSummary': 'A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short children born small for gestational age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronological Age ≥ 4\n* Before the adolescence, Tuner stage I (breast)\n* Height \\<3rd percentile for age\n* Normal thyroid function\n\nExclusion Criteria:\n\n* Growth hormone was administered for 12 months or longer in the past\n* Treated with estrogen or adrenal androgens for 12 months or longer in the past\n* Malignancy, CNS Trauma, Psychiatric Disorder\n* endocrine and/or metabolic disorders\n* growth failure caused by other disorders'}, 'identificationModule': {'nctId': 'NCT02770157', 'acronym': 'SGA', 'briefTitle': 'Efficacy and Safety of DA-3002 in Short Children Borns SGA.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Short Children Born Small for Gestational Age.', 'orgStudyIdInfo': {'id': 'DA3002_SGA_III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DA-3002', 'description': '1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week).', 'interventionNames': ['Drug: DA-3002']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Genotropin®', 'description': '1.44 IU (0.48mg)/kg/week of Genotropin is injected for 52 weeks by changing injecting areas(six or seven times per week).', 'interventionNames': ['Drug: Genotropin®']}, {'type': 'OTHER', 'label': 'Non-treatment control group', 'description': 'After no treatment for 26 weeks, 1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week).', 'interventionNames': ['Drug: DA-3002']}], 'interventions': [{'name': 'DA-3002', 'type': 'DRUG', 'armGroupLabels': ['DA-3002', 'Non-treatment control group']}, {'name': 'Genotropin®', 'type': 'DRUG', 'armGroupLabels': ['Genotropin®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dong kyu Jin, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul Samsung Medical center.'}, {'name': 'Byung Kyu Suh, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital, The Catholic University of Korea"}, {'name': 'Cheol Woo Ko, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Hospital'}, {'name': 'Kee Hyoung Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}, {'name': 'Han Wook Yoo, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}, {'name': 'Choong Ho Shin, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Jin Soon Hwang, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aju University Hospital'}, {'name': 'Ho Seong Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Severance Children's Hospital Yonsei University"}, {'name': 'Woo Young Jeong, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan University Hospital'}, {'name': 'Chang Jong Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam National University Hospital'}, {'name': 'Heon Suk Han, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chungbuk National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}