Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)
NCT ID: NCT02380235
Last Updated: 2017-06-16
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
600 participants
INTERVENTIONAL
2014-12-31
2017-07-31
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
0.12mg/kg/w
PEG-somatropin
0.20mg/kg/w
PEG-somatropin
0.12mg/kg/w
PEG-Somatropin
0.20mg/kg/w
PEG-somatropin
0.20mg/kg/w
PEG-somatropin
0.12mg/kg/w
Interventions
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PEG-somatropin
0.20mg/kg/w
PEG-somatropin
0.12mg/kg/w
Eligibility Criteria
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Inclusion Criteria
* 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.
* Height velocity (HV) ≤5.0 cm/yr.
* GH stimulation test with two different mechanisms affirms that GH peak concentration of patients' plasma\<10.0ng/ml.
* Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than his/her chronological age (CA).
* Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.
* Receive no prior GH treatment within 6 months.
* Sign informed consent.
Exclusion Criteria
* Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis Be antigen (HBeAg).
* People with known highly allergic constitution or allergy to the drug of the study.
* People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency.
* Diabetic.
* Potential tumor patients (family history).
* 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.
* Subjects took part in other clinical trial study within 3 months.
* Other conditions which in the opinion of the investigator preclude enrollment into the study.
3 Years
18 Years
ALL
No
Sponsors
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Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Children's Hospital Affiliated to Capital Institute of Pediatrics
Beijing, Beijing Municipality, China
Chinese Academy of Medical Sciences &Peking Union Medical College
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Affiliated Hospital, Jiangnan University
Wuxi, Jiangsu, China
First Hospital of Jilin University
Changchun, Jilin, China
Shandong Provincial Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
West China Second University Hospital
Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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GenSci 004 CT-2
Identifier Type: -
Identifier Source: org_study_id
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