Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency
NCT ID: NCT02908958
Last Updated: 2017-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
900 participants
INTERVENTIONAL
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PEG-somatropin
Low dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
PEG-somatropin
High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
PEG-somatropin
Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
PEG-Somatropin
High dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
PEG-somatropin
High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
PEG-somatropin
Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
Interventions
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PEG-somatropin
High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
PEG-somatropin
Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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.
* Height velocity (HV) ≤5.0 cm/yr.
* GH provocation tests with two different mechanisms showed that GH peak concentration of the child is \< 10.0ng/ml.
* Bone age (BA) ≤9 years in girls or ≤ 10 years in boys, and the BA is 1 year less than the CA.
* Prepuberty status (Tanner I stage), age ≥3 years old, girls and boys are acceptable.
* The child did not receive the treatment of growth hormone within 6 months.
* Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, and they sign informed consent.
Exclusion Criteria
* The child has positive hepatitis B core antibody (HBc), hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg).
* The child is known as hypersensitivity to PEG Somatropin.
* The child has severe cardiopulmonary, hematological diseases, malignant tumors, general infection or immunodeficiency diseases.
* The child has potential tumor (family history).
* The child has diabetics.
* 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.
* The child took part in other clinical trials within 3 months.
* Other conditions are excluded when the investigator preclude the enrollment into the study.
3 Years
18 Years
ALL
No
Sponsors
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The Children's Hospital of Zhejiang University School of Medicine
OTHER
The Second Hospital of Anhui Medical University
OTHER
Guangzhou Women and Children's Medical Center
OTHER
First People's Hospital of Hangzhou
OTHER
Qilu Hospital of Shandong University
OTHER
Zhejiang Provincial People's Hospital
OTHER
Zhejiang Provincial Hospital of TCM
OTHER
Central South University
OTHER
Southwest Hospital, China
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
Shanghai Children's Medical Center
OTHER
Second Affiliated Hospital of Wenzhou Medical University
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Xiangya Hospital of Central South University
OTHER
Shaoxing Second Hospital
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Junfen Fu, PhD
Role: PRINCIPAL_INVESTIGATOR
The Children's Hospital of Zhejiang University School of Medicine
Locations
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The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Wuhu No.1 People's Hospital
Wuhu, Anhui, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Harbin Children's Hospital
Harbin, Heilongjiang, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Children's Hospital of Changchun
Changchun, Jilin, China
Qilu Children's Hospital of Shandong University
Jinan, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Chengdu Women and Children's Central Hospital
Chengdu, Sichuan, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The Children's Hospital ,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial Hospital of Traditional Chinese Medcine Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Ningbo Women and Children's Hospital
Ningbo, Zhejiang, China
Shaoxing Second Hospital
Shaoxing, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Southwest Hospital, Third Military Medical University
Chongqing, , China
Shanghai Children's Medical Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Deyun Liu, MD
Role: primary
Jiayan Pan, MD
Role: primary
Qun Lian, MD
Role: primary
Li Liu, MD
Role: primary
Shunye Zhu, MD
Role: primary
Dan Lan, MD
Role: primary
Hong Yu, MD
Role: primary
Xingxing Zhang, MD
Role: primary
Lizhi Cao, MD
Role: primary
Jing Liu, MD
Role: primary
Dongmei Zhao, MD
Role: primary
Junhua Dong, MD
Role: primary
Xinran Cheng, MD
Role: primary
Mingjuan Dai, MD
Role: primary
Junfen Fu, PhD
Role: primary
Qin Dong
Role: primary
Xiaoming Luo, MD
Role: primary
Jianping Zhang, MD
Role: primary
Manyan Zhang, MD
Role: primary
Xianjiang Jin, MD
Role: primary
Wei Liao, MD
Role: primary
Xiaodong Huang, MD
Role: primary
References
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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.
Other Identifiers
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GenSci 004 CT-Zhejiang
Identifier Type: -
Identifier Source: org_study_id
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