A Novel Y-Shaped Pegylated Recombinant Human Growth Hormone for Children With Growth Hormone Deficiency
Primary result · GVResult — go to the resultLS means difference −0.127 95% CI −0.4868 to 0.2332Authors' conclusion
Pegpesen was noninferior to daily rhGH, with similar safety, lower dosage requirements, thus presenting a new therapeutic option for children with GHD.
Study context
- Population
- Children with growth hormone deficiency (GHD), 23 centers in Chinarandomized 2:1
- Participants
- 391 children
- Comparison
- Once-weekly Pegpesen vs daily recombinant human growth hormone (rhGH)
- Primary endpoint
- Growth velocity (GV)
- Follow-up
- 52 weeks
Methodological detailsmulticenter, phase 3, noninferiority
- Multicenter
- Phase 3
- Noninferiority
Primary result
GV
LS means difference
−0.127
95% CI −0.4868 to 0.2332
By group
Pegpesenvs Daily rhGH
LS means difference −0.127 (95% CI −0.4868 to 0.2332)
As reported in the abstract
Secondary outcomes
| Outcome | P value |
|---|---|
| ΔHt SDS CA and ΔHt SDS BASimilar across both groups | all P > .05 |
Adherence
- Adherence comparable between groups
Safety
- Safety profiles comparable between groups
Original publication
A Novel Y-Shaped Pegylated Recombinant Human Growth Hormone for Children With Growth Hormone Deficiency. J Clin Endocrinol Metab. Published 28 November 2024. doi:10.
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