Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-22 @ 7:23 AM
Study NCT ID:
NCT02380235
Status:
UNKNOWN
Last Update Posted:
2017-06-16
First Post:
2015-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-14', 'studyFirstSubmitDate': '2015-03-02', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ht SDSca', 'timeFrame': 'Baseline, 4,12,26 weeks after initiating treatment', 'description': 'Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth Hormone Deficiency']}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad of population of children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Before starting treatment, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.\n\n * According to the height statistical data of Chinese children's physique development in nine cities in 2005,height is lower than the third percentile of growth curve of normal children with the same age and gender.\n * Height velocity (HV) ≤5.0 cm/yr.\n * GH stimulation test with two different mechanisms affirms that GH peak concentration of patients' plasma\\<10.0ng/ml.\n * Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than his/her chronological age (CA).\n* Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.\n* Receive no prior GH treatment within 6 months.\n* Sign informed consent.\n\nExclusion Criteria:\n\n* People with abnormal liver or kidney function (ALT\\> 2 times the upper limit of normal value, Cr\\> the upper limit of normal value).\n* Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis Be antigen (HBeAg).\n* People with known highly allergic constitution or allergy to the drug of the study.\n* People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency.\n* Diabetic.\n* Potential tumor patients (family history).\n* Abnormal growth and development, such as Turner syndrome, constitutional delay of growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome.\n* Subjects 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': 'NCT02380235', 'briefTitle': 'Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun GeneScience Pharmaceutical Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'GenSci 004 CT-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEG-somatropin', 'description': '0.12mg/kg/w', 'interventionNames': ['Biological: PEG-somatropin']}, {'type': 'EXPERIMENTAL', 'label': 'PEG-Somatropin', 'description': '0.20mg/kg/w', 'interventionNames': ['Biological: PEG-somatropin']}], 'interventions': [{'name': 'PEG-somatropin', 'type': 'BIOLOGICAL', 'description': '0.20mg/kg/w', 'armGroupLabels': ['PEG-Somatropin', 'PEG-somatropin']}, {'name': 'PEG-somatropin', 'type': 'BIOLOGICAL', 'description': '0.12mg/kg/w', 'armGroupLabels': ['PEG-Somatropin', 'PEG-somatropin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': "Children's Hospital Affiliated to Capital Institute of Pediatrics", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Chinese Academy of Medical Sciences &Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Wuxi', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Affiliated Hospital, Jiangnan University', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'facility': 'First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': "Children's Hospital of Shanghai", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'West China Second University Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiaohua Feng', 'role': 'CONTACT', 'email': 'fengxiaohua@gensci-china.com', 'phone': '13610794989'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun GeneScience Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}