Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient：A Multicenter, Randomized, Open-label, Controlled Phase Ⅲ Clinical Trial|
- yearly growth velocity [ Time Frame: 6 months ] [ Designated as safety issue: No ]growth velocity add as GV was the primary outcome measure
- Ht SDSca [ Time Frame: 6 months ] [ Designated as safety issue: No ]Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age
- IGF-l [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- IGFBP-3 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- bone maturity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
- recombinant human growth hormone
- peglyated growth hormone
|Wu Han, China|
|Principal Investigator:||Xiaoping Luo, Ph. D||Huazhong University of Science and Technology|