Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency

Growth Hormone Deficiency Clinical Trial

Official title:

Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial II

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02908958
• Other study ID #: GenSci 004 CT-Zhejiang
• Status: Recruiting
• Phase: Phase 4
• First received: September 19, 2016
• Last updated: June 13, 2017
• Start date: November 2014

Study information

• Verified date: September 2016
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: Xiaohua Feng
• Phone: 13610794989
• Email: fengxiaohua[@]gensci-china.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

Biological:
• PEG-somatropin
High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
• PEG-somatropin
Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.

Locations

Country	Name	City	State
China	Children's Hospital of Changchun	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital, Central South University	Changsha	Hunan
China	Chengdu Women and Children's Central Hospital	Chengdu	Sichuan
China	Southwest Hospital, Third Military Medical University	Chongqing
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong
China	The Third Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
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	Harbin Children's Hospital	Harbin	Heilongjiang
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Qilu Children's Hospital of Shandong University	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Ningbo Women and Children's Hospital	Ningbo	Zhejiang
China	Shanghai Children's Medical Center	Shanghai
China	Shaoxing Second Hospital	Shaoxing	Zhejiang
China	The Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Wuhu No.1 People's Hospital	Wuhu	Anhui
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (17)

Lead Sponsor

Collaborator

GeneScience Pharmaceuticals Co., Ltd.

Central South University, First Affiliated Hospital of Guangxi Medical University, First People's Hospital of Hangzhou, Guangzhou Women and Children's Medical Center, Qilu Hospital of Shandong University, Second Affiliated Hospital of Wenzhou Medical University, Shanghai Children's Medical Center, Shaoxing Second Hospital, Southwest Hospital, China, The Children's Hospital of Zhejiang University School of Medicine, The First Affiliated Hospital of Xiamen University, The Second Hospital of Anhui Medical University, Third Affiliated Hospital, Sun Yat-Sen University, Xiangya Hospital of Central South University, Zhejiang Provincial Hospital of TCM, Zhejiang Provincial People’s Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of Height Standard Deviation Score for Chronological Age before and after the treatment (?HtSDSCA)	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	HtSDSBA	HtSDSBA = (height at the evaluated time point-the mean value of normal children in the same gender and same age) / height SD of normal children in the same bone age and same gender	26 weeks
Secondary	Annual height velocity	Annual Growth Velocity (cm/yr) = 12×(Height at the end of treatment-Height at the beginning of treatment)/the treatment duration (month)	26 weeks
Secondary	Standard Deviation Score of serum IGF-1 (IGF-1 SDS)	IGF-1 SDS = (actual concentration of IGF-1-the median of IGF-1 concentration of normal children in the age and same gender) / SD of IGF-1 concentration of normal children in the same gender and same age	26 weeks
Secondary	Bone Maturation	Bone Maturation = (BA at the end of treatment-BA at the beginning of treatment)/ the treatment duration (Year)	26 weeks