Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency
NCT ID: NCT03249480
Last Updated: 2017-08-15
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
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PEG-somatropin
30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.
PEG-somatropin
30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.
Interventions
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PEG-somatropin
30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.
Eligibility Criteria
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Inclusion Criteria
1. According to statistical height data of physical development of Chinese children in nine cities in 2005, the height is lower than 3rd percentile growth curve of the same age, same sex normal children;
2. Height velocity (HV) ≤5.0 cm / yr;
3. GH provocative tests (with two drugs of different mechanism of action) confirmed plasma GH peak \<10.0 ng / ml;
4. bone age for girl≤9 years old, for Boy≤10 years old, bone age is one year or more later than the actual age, that is the actual age - bone age ≥ 1 year;
* Before puberty (Tanner I stage), age≥3 years old, male or female;
* Have not received hormone therapy within 6 months;
* Subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.
Exclusion Criteria
* Patients positive for hepatitis B c-antibody (HBcAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg);
* Patients with known hypersensitivity to PEG Somatropin or Somatropin or any other components of the study product;
* Patients with severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases;
* Potential cancer patients (family history);
* Patients with diabetics;
* Patients with other growth disorders, such as Turner's syndrome, sexual physical delayed puberty, Laron syndrome, growth hormone receptor deficiency, girls with slowly growing who did not rule out chromosomal abnormalities;
* Patients with congenital bone dysplasia or scoliosis;
* Subjects took part in other clinical trial study during 3 months;
* Other conditions in which the investigator preclude enrollment into the study.
3 Years
18 Years
ALL
No
Sponsors
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Beijing Children's Hospital
OTHER
Tianjin Medical University General Hospital
OTHER
Peking University Third Hospital
OTHER
China-Japan Friendship Hospital
OTHER
Dalian Children's Hospital
OTHER
Xian Children's Hospital
OTHER_GOV
Wuhan Children's Hospital
OTHER
Fuzhou Children s Hospital
UNKNOWN
Anhui Provincial Children's Hospital
OTHER
Hunan Children's Hospital
OTHER_GOV
Shenzhen Children's Hospital
OTHER_GOV
Children's Hospital of Hebei Province
OTHER
Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
Zhengzhou Children's Hospital, China
OTHER
Children's Hospital of Soochow University
OTHER
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
Kunming Children's Hospital
OTHER
The First People's Hospital of Yunnan
OTHER
Xuzhou Children's Hopspital
UNKNOWN
Henan Provincial People's Hospital
OTHER
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
The Second Hospital of Hebei Medical University
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Union Hospital of Tongji Medical College of HUST
UNKNOWN
Wuxi Women's & Children's Hospital
OTHER
The Second Affiliated Hospital of Kunming Medical University
OTHER
Nanjing Children's Hospital
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Chunxiu Gong
Role: PRINCIPAL_INVESTIGATOR
Beijing Children's Hospital
Locations
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Anhui Provincial Children's Hospital
Hefei, Anhui, China
Fuzhou Children s Hospital
Fuzhou, Fujian, China
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiangzhuang, Hebei, China
Children's Hospital of Hebei Province
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Children's Hospital of Zhengzhou
Zhengzhou, Henan, China
Henan Provincal People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Henan University of TCM
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, HUST
Wuhan, Hubei, China
Wuhan Children's Hospital
Wuhan, Hubei, China
Hunan Children's Hospital
Changsha, Hunan, China
Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region
Nanjing, Jiangsu, China
Nanjing Children's Hospital
Nanjing, Jiangsu, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Wuxi Children's Hospital
Wuxi, Jiangsu, China
Xuzhou Children's Hpspital
Xuzhou, Jiangsu, China
Dalian Children's Hospital
Dalian, Liaoning, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Xi'an Children's Hospital
Xi’an, Shanxi, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Kunming Children's Hospital
Kunming, Yunnan, China
Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
China-Japan Friendship Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
Shenzhen Children's Hospital
Shenzhen, , China
Tianjin Medical University General Hospital
Tianjin, , China
Countries
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Central Contacts
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References
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Chen J, Zhong Y, Wei H, Chen S, Su Z, Liu L, Liang L, Lu P, Chen L, Chen R, Ni S, Wang X, Li L, Wang Y, Xu X, Xiao Y, Yao H, Liu G, Jin R, Cao B, Wu D, Su C, Li W, Qin M, Li X, Luo X, Gong C. Polyethylene glycol recombinant human growth hormone in Chinese prepubertal slow-growing short children: doses reported in a multicenter real-world study. BMC Endocr Disord. 2022 Aug 9;22(1):201. doi: 10.1186/s12902-022-01101-8.
Other Identifiers
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GenSci 004 CT-GCX
Identifier Type: -
Identifier Source: org_study_id
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