This study is conducted in China only. The purpose is to demonstrate the efficacy and safety of once weekly dosing of TransCon hGH, a long-acting growth hormone product, compare to once-daily dosing of human growth hormone (hGH) after 52 weeks of treatment in prepubertal children with growth hormone deficiency (GHD).
Not Provided
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Once weekly subcutaneous injection
Once daily subcutaneous injection
Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
Wuhan, Hubei, China
RECRUITINGAnnualized height velocity(AHV) at Week 52
Annualized height velocity at Week 52 for weekly TransCon hGH treatment and the daily hGH treatment groups
Time frame: 52 Weeks
AHV and the change from baseline over 52 weeks at each visit
AHV and the change from baseline for the TransCon hGH and the daily hGH treatment group over 52 weeks at each visit
Time frame: 52 Weeks
Height SDS and the change from baseline over 52 weeks
Height SDS and the change from baseline for the TransCon hGH and the daily hGH treatment group over 52 weeks
Time frame: 52 weeks
Serum IGF-1 and IGFBP-3 levels, and IGF-1 SDS, IGFBP-3 SDS, and the change from baseline over 52 weeks at each visit
Serum IGF-1 and IGFBP-3 levels, and IGF-1 SDS, IGFBP-3 SDS, and the change from baseline for the TransCon hGH and the daily hGH treatment group over 52 weeks at each visit
Time frame: 52 weeks
The percentage of participants achieving IGF-1 SDS 0 to +2.0
The normalization of IGF-1 SDS (percentage of participants achieving IGF-1 SDS 0 to +2.0 over 52 weeks for the TransCon hGH and the daily hGH treatment group
Time frame: 52 weeks
Incidence of Treatment-Emergent Adverse Events
Time frame: 52 weeks
The plasma concentration
pharmacokinetics measure of hGH over 52 weeks in TransCon hGH group
Time frame: 52 weeks
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