Clinical trial NCT02380235: Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Growth Hormone Deficiency
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-05
Enrollment: 600
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: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ht SDSca
timeFrame: Baseline, 4,12,26 weeks after initiating treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Children's Hospital Affiliated to Capital Institute of Pediatrics
state: Beijing
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences &Peking Union Medical College
state: Beijing
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated Hospital, Jiangnan University
state: Jiangsu
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Shanghai
state: Shanghai
city: Chengdu
country: China
facility: West China Second University Hospital
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Shanghai
country: China
facility: Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine
Study officials:
References: