Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-02 @ 4:04 PM
Study NCT ID:
NCT01786902
Status:
COMPLETED
Last Update Posted:
2017-10-19
First Post:
2013-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013006', 'term': 'Growth Hormone'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hwyoo@amc.seoul.kr', 'phone': '82-2-3010-3374', 'title': 'Dr. Hanwook Yoo', 'organization': 'Asan Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'DA-3002 Treatment Group', 'description': '1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)\n\nDA-3002', 'otherNumAtRisk': 36, 'otherNumAffected': 19, 'seriousNumAtRisk': 36, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Non-treatment Control Group', 'description': 'Height be measured with no treatment', 'otherNumAtRisk': 31, 'otherNumAffected': 14, 'seriousNumAtRisk': 31, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Strabismus correction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Immune system disorders'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 9}], 'organSystem': 'Infections and infestations'}], 'seriousEvents': [{'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Strabismus correction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annualized Height Velocity(cm/Year) After 26 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DA-3002 Treatment Group', 'description': '1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)\n\nDA-3002'}, {'id': 'OG001', 'title': 'Non-treatment Control Group', 'description': 'Height be measured with no treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '10.68', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '5.72', 'spread': '1.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks', 'description': 'Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.', 'unitOfMeasure': 'cm/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Height Standard Deviation Score After 26 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DA-3002 Treatment Group', 'description': '1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)\n\nDA-3002'}, {'id': 'OG001', 'title': 'Non-treatment Control Group', 'description': 'Height be measured with no treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks', 'description': 'The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Anti-growth Hormone Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DA-3002 Treatment Group', 'description': '1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)\n\nDA-3002'}, {'id': 'OG001', 'title': 'Non-treatment Control Group', 'description': 'Height be measured with no treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 26 weeks', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DA-3002 Treatment Group', 'description': '1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)\n\nDA-3002'}, {'id': 'FG001', 'title': 'Non-treatment Control Group', 'description': 'Height be measured with no treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DA-3002 Treatment Group', 'description': '1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)\n\nDA-3002'}, {'id': 'BG001', 'title': 'Non-treatment Control Group', 'description': 'Height be measured with no treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.75', 'spread': '1.79', 'groupId': 'BG000'}, {'value': '7.17', 'spread': '2.34', 'groupId': 'BG001'}, {'value': '6.96', 'spread': '2.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-18', 'studyFirstSubmitDate': '2013-02-06', 'resultsFirstSubmitDate': '2014-11-20', 'studyFirstSubmitQcDate': '2013-02-07', 'lastUpdatePostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-05-11', 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in Anti-growth Hormone Antibody', 'timeFrame': 'baseline and 26 weeks'}], 'primaryOutcomes': [{'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.'}], 'secondaryOutcomes': [{'measure': 'Changes in Height Standard Deviation Score After 26 Weeks', 'timeFrame': '26 weeks', 'description': 'The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['growth hormone'], 'conditions': ['Idiopathic Short Stature']}, 'descriptionModule': {'briefSummary': 'Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronological Age ≥ 4\n* Bone Age \\<11 (for girls) and \\<13 (for boys)\n* Height \\<3rd percentile for age\n* normal thyroid function\n\nExclusion Criteria:\n\n* endocrine and/or metabolic disorders\n* growth failure caused by other disorders\n* previous use of drugs that could interfere with Growth Hormone treatment'}, 'identificationModule': {'nctId': 'NCT01786902', 'briefTitle': 'Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'Open, Multi-Center, Controlled, Randomized Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-3002(Recombinant Humn Growth Hormone)Treatment in Children With Idiopathic Short Stature', 'orgStudyIdInfo': {'id': 'DA3002_ISS_III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DA-3002 Treatment group', 'description': '1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)', 'interventionNames': ['Drug: DA-3002']}, {'type': 'NO_INTERVENTION', 'label': 'Non-treatment control group', 'description': 'Height be measured with no treatment'}], 'interventions': [{'name': 'DA-3002', 'type': 'DRUG', 'otherNames': ['Recombinant Human Growth Hormone'], 'armGroupLabels': ['DA-3002 Treatment group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hanwook Yoo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}, {'name': 'Byungkyu Suh, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Seoul St. Mary's Hospital"}, {'name': 'Cheolwoo Ko, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyungpook National University Hospital'}, {'name': 'Keehyoung Lee, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Korea University Anam Hospitial'}, {'name': 'Dongkyu Jin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Samsung Medical Center'}, {'name': 'Choongho Shin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Jinsoon Hwang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aju University Hospital'}, {'name': 'Hoseong Kim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Severance Children's Hospital Yonsei University"}, {'name': 'Wooyoung Jeong, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pusan University Hospital'}, {'name': 'Chanjong Kim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chonnam National University Hospital'}, {'name': 'Heonsuk Han, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chungbuk National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}