Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT02908958
Status:
UNKNOWN
Last Update Posted:
2017-06-14
First Post:
2016-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency
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': 900}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2016-09-19', 'studyFirstSubmitQcDate': '2016-09-20', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA)', 'timeFrame': '26 weeks', 'description': 'HtSDSCA = (Height at the evaluated time point- the mean value of normal children in the same gender and same age) / the height SD of normal children in the same gender and same age'}], 'secondaryOutcomes': [{'measure': 'HtSDSBA', 'timeFrame': '26 weeks', 'description': 'HtSDSBA = (height at the evaluated time point-the mean value of normal children in the same gender and same age) / height SD of normal children in the same bone age and same gender'}, {'measure': 'Annual height velocity', 'timeFrame': '26 weeks', 'description': 'Annual Growth Velocity (cm/yr) = 12×(Height at the end of treatment-Height at the beginning of treatment)/the treatment duration (month)'}, {'measure': 'Standard Deviation Score of serum IGF-1 (IGF-1 SDS)', 'timeFrame': '26 weeks', 'description': 'IGF-1 SDS = (actual concentration of IGF-1-the median of IGF-1 concentration of normal children in the age and same gender) / SD of IGF-1 concentration of normal children in the same gender and same age'}, {'measure': 'Bone Maturation', 'timeFrame': '26 weeks', 'description': 'Bone Maturation = (BA at the end of treatment-BA at the beginning of treatment)/ the treatment duration (Year)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth Hormone Deficiency']}, 'referencesModule': {'references': [{'pmid': '36034802', 'type': 'DERIVED', 'citation': 'Jiang Z, Chen X, Dong G, Lou Y, Zhang J, Cheng X, Pan J, Liao W, Wu J, Huang X, Jin X, Liu D, Zeng T, Zhu S, Dong Q, Luo X, Lan D, Cao L, Zhang X, Liu J, Dai M, Zhang M, Liu L, Dong J, Zhao D, Ni S, Fu J. Short-term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency: A randomized, dose-comparison study. Front Pharmacol. 2022 Aug 11;13:955809. doi: 10.3389/fphar.2022.955809. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to 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, the child is diagnosed as GHD according to medical history,clinical symptoms and signs, GH provocation tests and imaging examinators and other examinators.\n* According to the height statistical data of Chinese children's physical development in nine cities in 2015, the height of the child is lower than the third percentile of normal children's growth curve in the same age and same gender.\n* Height velocity (HV) ≤5.0 cm/yr.\n* GH provocation tests with two different mechanisms showed that GH peak concentration of the child is \\< 10.0ng/ml.\n* Bone age (BA) ≤9 years in girls or ≤ 10 years in boys, and the BA is 1 year less than the CA.\n* Prepuberty status (Tanner I stage), age ≥3 years old, girls and boys are acceptable.\n* The child did not receive the treatment of growth hormone within 6 months.\n* Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, and they sign informed consent.\n\nExclusion Criteria:\n\n* The child is dysfunction of liver and kidney (ALT) 2 times of the upper limit of normal value, Cr\\> the upper limit of normal value).\n* The child has positive hepatitis B core antibody (HBc), hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg).\n* The child is known as hypersensitivity to PEG Somatropin.\n* The child has severe cardiopulmonary, hematological diseases, malignant tumors, general infection or immunodeficiency diseases.\n* The child has potential tumor (family history).\n* The child has diabetics.\n* The child has abnormal growth and development, such as Turner's syndrome, constitutional delay of growth and puberty, Laron syndrome, growth hormone receptor deficiency, short stature girls with potential chromosomal abnormalities.\n* The child took part in other clinical trials within 3 months.\n* Other conditions are excluded when the investigator preclude the enrollment into the study."}, 'identificationModule': {'nctId': 'NCT02908958', 'briefTitle': 'Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun GeneScience Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial II', 'orgStudyIdInfo': {'id': 'GenSci 004 CT-Zhejiang'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEG-somatropin', 'description': 'Low dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.', 'interventionNames': ['Biological: PEG-somatropin']}, {'type': 'EXPERIMENTAL', 'label': 'PEG-Somatropin', 'description': 'High dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.', 'interventionNames': ['Biological: PEG-somatropin']}], 'interventions': [{'name': 'PEG-somatropin', 'type': 'BIOLOGICAL', 'description': 'High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.', 'armGroupLabels': ['PEG-Somatropin', 'PEG-somatropin']}, {'name': 'PEG-somatropin', 'type': 'BIOLOGICAL', 'description': 'Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.', 'armGroupLabels': ['PEG-Somatropin', 'PEG-somatropin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Deyun Liu, MD', 'role': 'CONTACT'}], 'facility': 'The Second Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Wuhu', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiayan Pan, MD', 'role': 'CONTACT'}], 'facility': "Wuhu No.1 People's Hospital", 'geoPoint': {'lat': 31.35259, 'lon': 118.42947}}, {'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qun Lian, MD', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Liu, MD', 'role': 'CONTACT'}], 'facility': "Guangzhou Women and Children's Medical Center", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shunye Zhu, MD', 'role': 'CONTACT'}], 'facility': 'The Third Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dan Lan, MD', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Yu, MD', 'role': 'CONTACT'}], 'facility': "Harbin Children's Hospital", 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingxing Zhang, MD', 'role': 'CONTACT'}], 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lizhi Cao, MD', 'role': 'CONTACT'}], 'facility': 'Xiangya Hospital, Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Liu, MD', 'role': 'CONTACT'}], 'facility': "Children's Hospital of Changchun", 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dongmei Zhao, MD', 'role': 'CONTACT'}], 'facility': "Qilu Children's Hospital of Shandong University", 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junhua Dong, MD', 'role': 'CONTACT'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinran Cheng, MD', 'role': 'CONTACT'}], 'facility': "Chengdu Women and Children's Central Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingjuan Dai, MD', 'role': 'CONTACT'}], 'facility': "Hangzhou First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junfen Fu, PhD', 'role': 'CONTACT'}], 'facility': "The Children's Hospital ,Zhejiang University School of Medicine", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin Dong', 'role': 'CONTACT'}], 'facility': 'Zhejiang Provincial Hospital of Traditional Chinese Medcine Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoming Luo, MD', 'role': 'CONTACT'}], 'facility': "Zhejiang Provincial People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianping Zhang, MD', 'role': 'CONTACT'}], 'facility': "Ningbo Women and Children's Hospital", 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'city': 'Shaoxing', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Manyan Zhang, MD', 'role': 'CONTACT'}], 'facility': 'Shaoxing Second Hospital', 'geoPoint': {'lat': 30.00237, 'lon': 120.57864}}, {'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianjiang Jin, MD', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Liao, MD', 'role': 'CONTACT'}], 'facility': 'Southwest Hospital, Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaodong Huang, MD', 'role': 'CONTACT'}], 'facility': "Shanghai Children's Medical Center", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiaohua Feng', 'role': 'CONTACT', 'email': 'fengxiaohua@gensci-china.com', 'phone': '13610794989'}], 'overallOfficials': [{'name': 'Junfen Fu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Children's Hospital of Zhejiang University School of Medicine"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun GeneScience Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "The Children's Hospital of Zhejiang University School of Medicine", 'class': 'OTHER'}, {'name': 'The Second Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}, {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': "Zhejiang Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Zhejiang Provincial Hospital of TCM', 'class': 'OTHER'}, {'name': 'Central South University', 'class': 'OTHER'}, {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': "Shanghai Children's Medical Center", 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'Shaoxing Second Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}