Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
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
 population of children. Half of participants will receive the high dose, while the other half
 will receive the low dose.
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 B e 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.

 -  Potential tumor patients (family history).

 -  Diabetic.

 -  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.