Clinical trial NCT02908958: Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency
Official title: Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Growth Hormone Deficiency
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The Children's Hospital of Zhejiang University School of Medicine
name: The Second Hospital of Anhui Medical University
name: Guangzhou Women and Children's Medical Center
name: First People's Hospital of Hangzhou
name: Qilu Hospital of Shandong University
name: Zhejiang Provincial People's Hospital
name: Zhejiang Provincial Hospital of TCM
name: Central South University
name: Southwest Hospital, China
name: First Affiliated Hospital of Guangxi Medical University
name: Shanghai Children's Medical Center
name: Second Affiliated Hospital of Wenzhou Medical University
name: The First Affiliated Hospital of Xiamen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Xiangya Hospital of Central South University
name: Shaoxing Second Hospital
First posted: 2016-09-21
Enrollment: 900
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA)
timeFrame: 26 weeks
Secondary outcomes:
measure: HtSDSBA
timeFrame: 26 weeks
measure: Annual height velocity
timeFrame: 26 weeks
measure: Standard Deviation Score of serum IGF-1 (IGF-1 SDS)
timeFrame: 26 weeks
measure: Bone Maturation
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Wuhu
country: China
facility: Wuhu No.1 People's Hospital
state: Anhui
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Harbin
country: China
facility: Harbin Children's Hospital
state: Heilongjiang
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Changchun
country: China
facility: Children's Hospital of Changchun
state: Jilin
city: Jinan
country: China
facility: Qilu Children's Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Chengdu
country: China
facility: Chengdu Women and Children's Central Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Children's Hospital ,Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital of Traditional Chinese Medcine Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Women and Children's Hospital
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing Second Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Chongqing
country: China
facility: Southwest Hospital, Third Military Medical University
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
Study officials:
affiliation: The Children's Hospital of Zhejiang University School of Medicine
name: Junfen Fu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.