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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
0.1 mg/kg/wk once a week for 25 weeks
0.2 mg/kg/wk once a week for 25 weeks
0.25 mg/kg/wk, once a day for 25 weeks
Growth velocity
Time frame: 25 weeks
height standard deviation score for chronological age (Ht SDSCA)
Time frame: 25 weeks
IGF-1
Time frame: 25 weeks
IGFBP3
Time frame: 25 weeks
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