Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)

Growth Hormone Deficiency Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02380235
• Other study ID #: GenSci 004 CT-2
• Status: Recruiting
• Phase: Phase 4
• First received: March 2, 2015
• Last updated: June 14, 2017
• Start date: December 2014
• Est. completion date: July 2017

Study information

• Verified date: June 2017
• 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

This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad of population of children.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 2017
• 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, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.

• According to the height statistical data of Chinese children's physique development in nine cities in 2005,height is lower than the third percentile of growth curve of normal children with the same age and gender.

• Height velocity (HV) =5.0 cm/yr.

• GH stimulation test with two different mechanisms affirms that GH peak concentration of patients' plasma<10.0ng/ml.

• Bone age (BA) =9 years in girls and =10 years in boys, at least 1 year less than his/her chronological age (CA).

• Be in preadolescence (Tanner stage 1) and have a CA ? 3 years.

• Receive no prior GH treatment within 6 months.

• Sign informed consent.

Exclusion Criteria:

• People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal value, Cr> the upper limit of normal value).

• Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis Be antigen (HBeAg).

• People with known highly allergic constitution or allergy to the drug of the study.

• People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency.

• Diabetic.

• Potential tumor patients (family history).

• Abnormal growth and development, such as Turner syndrome, constitutional delay of growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome.

• Subjects took part in other clinical trial study within 3 months.

• Other conditions which in the opinion of the investigator preclude enrollment into the study.

Related Conditions & MeSH terms

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

Intervention

Biological:
• PEG-somatropin
0.20mg/kg/w
• PEG-somatropin
0.12mg/kg/w

Locations

Country	Name	City	State
China	Children's Hospital Affiliated to Capital Institute of Pediatrics	Beijing	Beijing
China	Chinese Academy of Medical Sciences &Peking Union Medical College	Beijing	Beijing
China	First Hospital of Jilin University	Changchun	Jilin
China	West China Second University Hospital	Chengdu	Sichuan
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Shandong Provincial Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Children's Hospital of Shanghai	Shanghai	Shanghai
China	Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine	Shanghai
China	Affiliated Hospital, Jiangnan University	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 4,12,26 weeks after initiating treatment