Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children
Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children
The purpose of the multicenter, randomized, open-label, controlled phase II study is to
 determine whether pegylated recombinant human growth hormone is effective in the treatment of
 children with growth hormone deficiency.
Inclusion Criteria:

 -  have a height less than two standard deviations (SD) below the median height for
 individuals of the same age or height, a growth velocity (GV) ≤4 cm/yr, a GH peak
 concentration <7 ng/ml in two different provocative tests, a bone age (BA; ≤9 years in
 girls and ≤10 years in boys) at least 2 years less than his/her chronological age
 (CA);

 -  be in preadolescence (Tanner stage 1) and have a CA >3 years;

 -  have a height value recorded 3 months before the start of GH treatment to calculate
 pre-treatment GV;

 -  receive no prior GH treatment.

 -  sign informed consent

 Exclusion Criteria:

 -  patients with severe cardiopulmonary

 -  patients with hematological diseases

 -  a current or past history of malignant tumors

 -  immunodeficiency diseases

 -  mental diseases

 -  patients positive for hepatitis B e-antibody (HBeAb)

 -  hepatitis B surface antigen (HBsAg)

 -  hepatitis B e antigen (HBeAg)

 -  patients with other growth disorders, such as Turner syndrome

 -  constitutional delay of growth and puberty, and Laron syndrome