Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children

Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study

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