A Phase 4 interventional study of PEG-somatropin and PEG-somatropin in Growth Hormone Deficiency, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Status unknown at 22 sites in China. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-06-14.
Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment
To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.
164 studies on the registry are indexed under Dwarfism, Pituitary; 25 are open to participants now.
This study's planned enrollment of 900 is above the median of 72 across 122 interventional studies indexed under Dwarfism, Pituitary.
Browse Dwarfism, Pituitary studies →Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 108 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
Biological: PEG-somatropin
High dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
Biological: PEG-somatropin
High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA)
HtSDSCA = (Height at the evaluated time point- the mean value of normal children in the same gender and same age) / the height SD of normal children in the same gender and same age
Time frame: 26 weeks
HtSDSBA
HtSDSBA = (height at the evaluated time point-the mean value of normal children in the same gender and same age) / height SD of normal children in the same bone age and same gender
Time frame: 26 weeks
Annual height velocity
Annual Growth Velocity (cm/yr) = 12×(Height at the end of treatment-Height at the beginning of treatment)/the treatment duration (month)
Time frame: 26 weeks
Standard Deviation Score of serum IGF-1 (IGF-1 SDS)
IGF-1 SDS = (actual concentration of IGF-1-the median of IGF-1 concentration of normal children in the age and same gender) / SD of IGF-1 concentration of normal children in the same gender and same age
Time frame: 26 weeks
Bone Maturation
Bone Maturation = (BA at the end of treatment-BA at the beginning of treatment)/ the treatment duration (Year)
Time frame: 26 weeks
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Changchun GeneScience Pharmaceutical Co., Ltd.