Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency
1 other identifier
interventional
900
1 country
28
Brief Summary
To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with growth hormone deficiency, as well as to study the dosage of PEG Somatropin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedAugust 15, 2017
July 1, 2017
2.6 years
July 24, 2017
August 10, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Ht SDSca (Height Standard Deviation Score for Chronological Age)
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
Baseline
Change of yearly growth velocity from baseline to 26 weeks
Height velocity calculate by formula
Baseline, 26 weeks after initiating treatment
Ht SDSca
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
26 weeks after initiating treatment
Secondary Outcomes (4)
Ht SDSBA (Height Standard Deviation Score for Bone Age)
Baseline,26 weeks after initiating treatment
IGF-1 SDS (IGF-1 Standard Deviation Score)
Baseline,26 weeks after initiating treatment
IGFBP-3 SDS (IGFBP-3 Standard Deviation Score)
Baseline,26 weeks after initiating treatment
Skeletal maturity
Baseline,26 weeks after initiating treatment
Study Arms (1)
PEG-somatropin
EXPERIMENTAL30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.
Interventions
30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.
Eligibility Criteria
You may qualify if:
- Diagnosed as GHD before starting treatment, according to medical history, clinical symptoms and signs, GH provocation tests and imaging and other examinations:
- 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;
- Height velocity (HV) ≤5.0 cm / yr;
- GH provocative tests (with two drugs of different mechanism of action) confirmed plasma GH peak \<10.0 ng / ml;
- 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.
You may not qualify if:
- Dysfunction of liver and kidney (ALT\> 2 times the upper limit of normal, Cr\> upper limit of normal);
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changchun GeneScience Pharmaceutical Co., Ltd.lead
- Beijing Children's Hospitalcollaborator
- Tianjin Medical University General Hospitalcollaborator
- Peking University Third Hospitalcollaborator
- China-Japan Friendship Hospitalcollaborator
- Dalian Children's Hospitalcollaborator
- Xian Children's Hospitalcollaborator
- Wuhan Children's Hospitalcollaborator
- Fuzhou Children s Hospitalcollaborator
- Anhui Provincial Children's Hospitalcollaborator
- Hunan Children's Hospitalcollaborator
- Shenzhen Children's Hospitalcollaborator
- Children's Hospital of Hebei Provincecollaborator
- Second Affiliated Hospital of Xi'an Jiaotong Universitycollaborator
- Zhengzhou Children's Hospital, Chinacollaborator
- Children's Hospital of Soochow Universitycollaborator
- Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Regioncollaborator
- First Affiliated Hospital of Kunming Medical Universitycollaborator
- Kunming Children's Hospitalcollaborator
- The First People's Hospital of Yunnancollaborator
- Xuzhou Children's Hopspitalcollaborator
- Henan Provincial People's Hospitalcollaborator
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicinecollaborator
- First Affiliated Hospital of Harbin Medical Universitycollaborator
- The Second Hospital of Hebei Medical Universitycollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- Union Hospital of Tongji Medical College of HUSTcollaborator
- Wuxi Women's & Children's Hospitalcollaborator
- The Second Affiliated Hospital of Kunming Medical Universitycollaborator
- Nanjing Children's Hospitalcollaborator
Study Sites (28)
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
Related Publications (1)
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.
PMID: 35945517DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chunxiu Gong
Beijing Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2017
First Posted
August 15, 2017
Study Start
January 1, 2015
Primary Completion
August 1, 2017
Last Updated
August 15, 2017
Record last verified: 2017-07