Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency
1 other identifier
interventional
900
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
22 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
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 19, 2016
CompletedFirst Posted
Study publicly available on registry
September 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedJune 14, 2017
September 1, 2016
2.6 years
September 19, 2016
June 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA)
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
26 weeks
Secondary Outcomes (4)
HtSDSBA
26 weeks
Annual height velocity
26 weeks
Standard Deviation Score of serum IGF-1 (IGF-1 SDS)
26 weeks
Bone Maturation
26 weeks
Study Arms (2)
PEG-somatropin
EXPERIMENTALLow dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
PEG-Somatropin
EXPERIMENTALHigh dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
Interventions
High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changchun GeneScience Pharmaceutical Co., Ltd.lead
- The Children's Hospital of Zhejiang University School of Medicinecollaborator
- The Second Hospital of Anhui Medical Universitycollaborator
- Guangzhou Women and Children's Medical Centercollaborator
- First People's Hospital of Hangzhoucollaborator
- Qilu Hospital of Shandong Universitycollaborator
- Zhejiang Provincial People's Hospitalcollaborator
- Zhejiang Provincial Hospital of TCMcollaborator
- Central South Universitycollaborator
- Southwest Hospital, Chinacollaborator
- First Affiliated Hospital of Guangxi Medical Universitycollaborator
- Shanghai Children's Medical Centercollaborator
- Second Affiliated Hospital of Wenzhou Medical Universitycollaborator
- The First Affiliated Hospital of Xiamen Universitycollaborator
- Third Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Xiangya Hospital of Central South Universitycollaborator
- Shaoxing Second Hospitalcollaborator
Study Sites (22)
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
Related Publications (1)
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.
PMID: 36034802DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Junfen Fu, PhD
The Children's Hospital of Zhejiang University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2016
First Posted
September 21, 2016
Study Start
November 1, 2014
Primary Completion
June 1, 2017
Last Updated
June 14, 2017
Record last verified: 2016-09