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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02908958
Other study ID # GenSci 004 CT-Zhejiang
Secondary ID
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
Health authority
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. completion date
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.

Study Design


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
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