Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-12 @ 12:00 AM
Study NCT ID:
NCT03245333
Status:
UNKNOWN
Last Update Posted:
2017-12-12
First Post:
2017-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Recombinant Human Growth Hormone Injection for Short Children With Small for Small for Gestational Age(SGA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'lastUpdateSubmitDate': '2017-12-10', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-08-07', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of height standard deviation score for chronological age (△Ht SDSCA)', 'timeFrame': '52 weeks', 'description': '△Ht SDS= Ht SDSafter treatment - Ht SDSbaseline Ht SDSCA = (height - reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint )'}], 'secondaryOutcomes': [{'measure': 'Height（Ht）at the end of treatment', 'timeFrame': 'Stage 1：52 weeks'}, {'measure': 'Height（Ht）at the end of treatment', 'timeFrame': 'Stage 2：Every 52 weeks, up to 3 years'}, {'measure': 'Annualized height velocity (HV)', 'timeFrame': 'Stage 1：52 weeks'}, {'measure': 'Annualized height velocity (HV)', 'timeFrame': 'Stage 2：Every 52 weeks, up to 3 years'}, {'measure': 'Bone age maturation', 'timeFrame': 'Stage 1：52 weeks'}, {'measure': 'Bone age maturation', 'timeFrame': 'Stage 2：Every 52 weeks, up to 3 years'}, {'measure': 'Mole ratio of IGF-1 and IGFBP-3', 'timeFrame': 'Stage 1：52 weeks'}, {'measure': 'Mole ratio of IGF-1 and IGFBP-3', 'timeFrame': 'Stage 2：Every 52 weeks, up to 3 years'}, {'measure': 'IGF-1 standard deviation score (SDS)', 'timeFrame': 'Stage 1：52 weeks'}, {'measure': 'IGF-1 standard deviation score (SDS)', 'timeFrame': 'Stage 2：Every 52 weeks, up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Small for Gestational Age Infant']}, 'descriptionModule': {'briefSummary': 'According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short SGA children, further to evaluate the efficacy and safety of the treatment of short SGA children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '24 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of full-term 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* 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 participating in the study.\n* Bone age\\<Chronological age+1.\n* Normal glucose regulation：Fasting blood-glucose \\< 5.6mmol/L, and 2 hours postprandial blood-glucose \\< 7.8mmol/L.\n* Gestational age was 37 to 42 weeks.\n* The subjects and their guardians signed informed consent.\n\nExclusion Criteria:\n\n* Subjects with Liver and renal insufficiency (ALT \\> 1.5 times of upper limit of normal value, Cr\\> upper limit of normal value).\n* Patients are positive for antibodies to hepatitis B core (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 growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome and growth hormone receptor deficiency.\n* Subjects who have received the treatment of GH.\n* Subjects took part in other clinical trial study within 3 months.\n* Children who have treated with other hormone (such as gonadal hormone and glucocorticoids etc, continuous administration of more than a month) and that may affect growth hormone secretion or action including oxygen male dragon, growth hormone releasing hormone, etc. within 3 months.\n* Other conditions which in the opinion of the investigator preclude enrollment into the study.'}, 'identificationModule': {'nctId': 'NCT03245333', 'briefTitle': 'A Study of Recombinant Human Growth Hormone Injection for Short Children With Small for Small for Gestational Age(SGA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun GeneScience Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Phase Ⅲ Clinical Study of Recombinant Human Growth Hormone Injection (JINTOPIN AQ) for Short Children With Small for Gestational Age(SGA)', 'orgStudyIdInfo': {'id': 'GenSci 030 CT-III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage 1-experimental group', 'description': 'JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）, for 52 weeks.', 'interventionNames': ['Drug: Recombinant Human Growth Hormone Injection']}, {'type': 'OTHER', 'label': 'Stage 1-negative control', 'description': 'observed only for 52 weeks.', 'interventionNames': ['Drug: Recombinant Human Growth Hormone Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2-experimental group', 'description': 'After completing the stage 1, experimental groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height.', 'interventionNames': ['Drug: Recombinant Human Growth Hormone Injection']}, {'type': 'OTHER', 'label': 'Stage 2-negative control', 'description': 'After completing the stage 1, negative control groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height.', 'interventionNames': ['Drug: Recombinant Human Growth Hormone Injection']}], 'interventions': [{'name': 'Recombinant Human Growth Hormone Injection', 'type': 'DRUG', 'otherNames': ['rhGH Injection'], 'description': 'Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.', 'armGroupLabels': ['Stage 1-experimental group', 'Stage 1-negative control', 'Stage 2-experimental group', 'Stage 2-negative control']}, {'name': 'Recombinant Human Growth Hormone Injection', 'type': 'DRUG', 'otherNames': ['rhGH Injection'], 'description': 'Stage 2: After completing phase 1, patients are administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd weeks to the final height.', 'armGroupLabels': ['Stage 1-experimental group', 'Stage 1-negative control', 'Stage 2-experimental group', 'Stage 2-negative control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', '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', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The first affiliated Hospital with Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'facility': "The Children's Hospital of Zhejiang University School of Medicine", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': "Beijing Children's Hospital, Capital Medical University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'facility': "Shanghai Children's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiaohua Feng', 'role': 'CONTACT', 'email': 'fengxiaohua@gensci-china.com', 'phone': '0431-85170552'}, {'name': 'Xiaoping Luo', 'role': 'CONTACT', 'email': 'xpluo@tjh.tjmu.edu.cn', 'phone': '+86-27-83663712'}]}, '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'}}}}