To Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children with Achondroplasia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Recombinant human growth hormone (15IU/5mg/3ml/bottle),0.05 mg/kg/d by subcutaneous injection for 52 weeks
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGChange From Baseline in Annualized Height Velocity (AHV) at Week 52
The change in AHV after 52 weeks treatment
Time frame: week 52
Change From Baseline in AHV
Change in AHV at week, week 13, week 26, week 39
Time frame: week 4, week 13, week 26, week 39
Change From Baseline in Height Standard Deviation Score (Ht SDS)
Change From Baseline in Ht SDS at week 4, week 13, week 26, week 39, week 52
Time frame: week 4, week 13, week 26, week 39, week 52
Change From Baseline in BMI Standard Deviation Score (BMI SDS)
Change From Baseline in BMI SDS at week 4, week 13, week 26, week 39, week 52
Time frame: week 4, week 13, week 26, week 39, week 52
Change From Baseline in Sitting Height/Leg Length ratio Standard Deviation Score (SH/LL SDS)
Change From Baseline in SH/LL SDS at week 4, week 13, week 26, week 39, week 52
Time frame: week 4, week 13, week 26, week 39, week 52
Change From Baseline in IGF-1 Standard Deviation Score (IGF -1 SDS)
Change From Baseline in IGF-1 SDS at week 4, week 13, week 26, week 39, week 52
Time frame: week 4, week 13, week 26, week 39, week 52
Change From Baseline in IGF-1/IGFBP-3 ratio
Change From Baseline in IGF-1/IGFBP-3 ratio at week 4, week 13, week 26, week 39, week 52
Time frame: week 4, week 13, week 26, week 39, week 52
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Change From Baseline in Bone Age/Chronological Age ratio (BA/CA)
Change From Baseline in BA/CA at week 52
Time frame: week 52