Growth Hormone Deficiency Clinical Trial
Official title:
Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient:A Multicenter, Randomized, Open-label, Controlled Phase Ⅲ Clinical Trial
This was a multicenter, randomized, open-label, parallel controlled phase III study, compared
pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration
formulation).
All the subjects were randomized into two groups, test group (PEG somatorpin) and control
group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled
in control group. Considering the case loss during the clinical study, 20% of the patients
were added in each of the group, that is 240 children were in test group and 120 children
were in control group, totally 360 children were enrolled in the phase III clinical study.
Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point
of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time
point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the
evaluation would be made when the treatment is finished.
n/a
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