Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-05 @ 11:31 AM
Study NCT ID:
NCT03221933
Status:
COMPLETED
Last Update Posted:
2017-12-12
First Post:
2017-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019382', 'term': 'Human Growth Hormone'}, {'id': 'D044382', 'term': 'Population Groups'}], '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'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'lastUpdateSubmitDate': '2017-12-10', 'studyFirstSubmitDate': '2017-07-16', 'studyFirstSubmitQcDate': '2017-07-17', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Height standard deviation score for chronological age (Ht SDSCA)', 'timeFrame': '26 weeks', 'description': 'HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)'}, {'measure': 'Height standard deviation score for chronological age (Ht SDSCA)', 'timeFrame': '52 weeks', 'description': 'HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)'}, {'measure': 'Height standard deviation score for chronological age (Ht SDSCA)', 'timeFrame': '78 weeks', 'description': 'HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)'}, {'measure': 'Height standard deviation score for chronological age (Ht SDSCA)', 'timeFrame': '104 weeks', 'description': 'HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)'}], 'secondaryOutcomes': [{'measure': 'ΔHtSDSCA', 'timeFrame': '26 weeks， 52 weeks，78 weeks and 104 weeks', 'description': 'Change in height SDS for chronological age (Ht SDSCA)'}, {'measure': 'Change in HV', 'timeFrame': '26 weeks， 52 weeks，78 weeks and 104 weeks', 'description': 'Change in annualized height velocity (HV)'}, {'measure': 'Change in bone age maturation', 'timeFrame': '26 weeks， 52 weeks，78 weeks and 104 weeks'}, {'measure': 'Change in mole ratio of IGF-1 and IGFBP-3', 'timeFrame': '26 weeks， 52 weeks，78 weeks and 104 weeks'}, {'measure': 'Change in PAH', 'timeFrame': '26 weeks， 52 weeks，78 weeks and 104 weeks', 'description': 'Change in prediction of adult height (PAH)'}, {'measure': 'Change in obesity prevalence', 'timeFrame': '26 weeks， 52 weeks，78 weeks and 104 weeks'}, {'measure': 'Change in overweight', 'timeFrame': '26 weeks， 52 weeks，78 weeks and 104 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Small for Gestational Age Infant']}, 'descriptionModule': {'briefSummary': 'To preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '90 Months', 'minimumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of small for gestational age, SGA.\n* Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders.\n* Prepubertal stage (Tanner I).\n* Without catch-up growth in two years after birth.\n* Height was lower than the mean -2SD of the values of normal children of the same age and gender when participating in the study.\n* A GH peak concentration \\>10µg/L in a provocative test within a year before participate in the study.\n* Bone age\\<Chronological age+1.\n* Normal glucose regulation：Fasting blood-glucose \\< 5.6mmol/L and 2-hour postprandial blood glucose\\< 7.8mmol/L.\n* Gestational age≥Gestational age≥ 36weeks + 4days.\n* Never accepted growth hormone treatment.\n* The subjects and their guardians signed informed consent.\n\nExclusion Criteria:\n\n* Subjects with Liver and renal insufficiency (ALT \\> 2 times of upper limit of normal value, Cr\\> upper limit of normal value).\n* Patients with positive for antibodies to hepatitis B core (anti-HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)。\n* Known highly allergic constitution or allergic to the test drug.\n* Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and hematological diseases, malignant tumors, or systemic infection, immunocompromised patients and patients with psychosis.\n* Subjects with other types of abnormal growth and development, such as Turner syndrome, constitutional delay of puberty, Laron syndrome, growth hormone receptor deficiency.\n* Subjects who have received the treatment of Somatropin or took part in other clinical trial study within 3 months.\n* Other conditions which in the opinion of the investigator preclude enrollment into the study.'}, 'identificationModule': {'nctId': 'NCT03221933', 'briefTitle': 'A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun GeneScience Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Phase Ⅱ Clinical Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for Gestational Age(SGA)', 'orgStudyIdInfo': {'id': 'GenSci 030 CT-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Somatropin Injection low dose group', 'description': '0.23mg/kg /wk，inject for seven divided doses.', 'interventionNames': ['Biological: Somatropin Injection low dose group', 'Biological: Somatropin Injection high dose group']}, {'type': 'EXPERIMENTAL', 'label': 'Somatropin Injection high dose group', 'description': '0.46mg/kg /wk，inject for seven divided doses.', 'interventionNames': ['Biological: Somatropin Injection low dose group', 'Biological: Somatropin Injection high dose group']}], 'interventions': [{'name': 'Somatropin Injection low dose group', 'type': 'BIOLOGICAL', 'description': '0.23mg/kg /wk，inject for seven divided doses', 'armGroupLabels': ['Somatropin Injection high dose group', 'Somatropin Injection low dose group']}, {'name': 'Somatropin Injection high dose group', 'type': 'BIOLOGICAL', 'description': '0.46mg/kg /wk，inject for seven divided dose', 'armGroupLabels': ['Somatropin Injection high dose group', 'Somatropin Injection low dose group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The first affiliated Hospital with Nanjing Medical Universit', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Children's Hospital of Zhejiang University School of Medicine", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Beijing', 'country': 'China', 'facility': "Beijing Children's Hospital of Capital Medical University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai Children's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xiaoping Luo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun GeneScience Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Tongji Hospital', 'class': 'OTHER'}, {'name': "Beijing Children's Hospital", 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, {'name': "Shanghai Children's Hospital", 'class': 'OTHER'}, {'name': "The Children's Hospital of Zhejiang University School of Medicine", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}